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Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors

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ClinicalTrials.gov Identifier: NCT02867592
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Results First Posted : November 28, 2022
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adrenal Cortical Carcinoma
Alveolar Soft Part Sarcoma
Central Nervous System Neoplasm
Childhood Clear Cell Sarcoma of Soft Tissue
Clear Cell Sarcoma of Soft Tissue
Ewing Sarcoma
Hepatoblastoma
Hepatocellular Carcinoma
Osteosarcoma
Recurrent Adrenal Cortical Carcinoma
Recurrent Alveolar Soft Part Sarcoma
Recurrent Clear Cell Sarcoma of Soft Tissue
Recurrent Ewing Sarcoma
Recurrent Hepatoblastoma
Recurrent Hepatocellular Carcinoma
Recurrent Kidney Wilms Tumor
Recurrent Malignant Solid Neoplasm
Recurrent Osteosarcoma
Recurrent Primary Malignant Central Nervous System Neoplasm
Recurrent Renal Cell Carcinoma
Recurrent Rhabdomyosarcoma
Recurrent Soft Tissue Sarcoma
Recurrent Thyroid Gland Medullary Carcinoma
Refractory Adrenal Cortical Carcinoma
Refractory Alveolar Soft Part Sarcoma
Refractory Clear Cell Sarcoma of Soft Tissue
Refractory Ewing Sarcoma
Refractory Hepatoblastoma
Refractory Hepatocellular Carcinoma
Refractory Malignant Solid Neoplasm
Refractory Osteosarcoma
Refractory Primary Central Nervous System Neoplasm
Refractory Primary Malignant Central Nervous System Neoplasm
Refractory Renal Cell Carcinoma
Refractory Rhabdomyosarcoma
Refractory Soft Tissue Sarcoma
Refractory Thyroid Gland Medullary Carcinoma
Refractory Wilms Tumor
Renal Cell Carcinoma
Rhabdomyosarcoma
Soft Tissue Sarcoma
Solid Neoplasm
Thyroid Gland Medullary Carcinoma
Wilms Tumor
Interventions Drug: Cabozantinib
Drug: Cabozantinib S-malate
Other: Pharmacological Study
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Hide Arm/Group Description Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 15 14 13 13 25 29
Completed 0 0 0 0 0 0
Not Completed 15 14 13 13 25 29
Reason Not Completed
Adverse Event             3             0             2             1             1             5
Death             0             0             0             1             0             1
Lack of Efficacy             8             10             8             8             12             17
Physician Decision             1             2             2             0             5             1
Protocol Violation             0             0             0             0             1             1
Withdrawal by Subject             0             1             0             1             3             3
Ineligible             1             1             0             0             2             0
No Treatment             1             0             0             0             0             0
Still on Therapy             0             0             0             0             1             0
Patient received concurrent anticancer or investigational therapy             0             0             0             0             0             1
Repeat Eligibility Studies (If Required) Are Outside The Parameters Required For Eligibility             1             0             1             2             0             0
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma Total
Hide Arm/Group Description Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 15 14 13 13 25 29 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 13 participants 13 participants 25 participants 29 participants 109 participants
<=18 years
7
  46.7%
6
  42.9%
8
  61.5%
11
  84.6%
22
  88.0%
17
  58.6%
71
  65.1%
Between 18 and 65 years
8
  53.3%
8
  57.1%
5
  38.5%
2
  15.4%
3
  12.0%
12
  41.4%
38
  34.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 13 participants 13 participants 25 participants 29 participants 109 participants
18.1
(7.3 to 26.8)
19.3
(5.7 to 26.8)
16.1
(10.1 to 26.3)
14.1
(8.9 to 27.1)
13.2
(5.6 to 19.5)
16.8
(9.1 to 22.3)
15.7
(5.6 to 27.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 13 participants 13 participants 25 participants 29 participants 109 participants
Female
5
  33.3%
5
  35.7%
8
  61.5%
10
  76.9%
15
  60.0%
10
  34.5%
53
  48.6%
Male
10
  66.7%
9
  64.3%
5
  38.5%
3
  23.1%
10
  40.0%
19
  65.5%
56
  51.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 13 participants 13 participants 25 participants 29 participants 109 participants
Hispanic or Latino
0
   0.0%
2
  14.3%
2
  15.4%
1
   7.7%
8
  32.0%
8
  27.6%
21
  19.3%
Not Hispanic or Latino
15
 100.0%
12
  85.7%
10
  76.9%
11
  84.6%
15
  60.0%
20
  69.0%
83
  76.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   7.7%
1
   7.7%
2
   8.0%
1
   3.4%
5
   4.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 13 participants 13 participants 25 participants 29 participants 109 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
  14.3%
1
   7.7%
2
  15.4%
2
   8.0%
1
   3.4%
8
   7.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
1
   3.4%
2
   1.8%
Black or African American
1
   6.7%
1
   7.1%
3
  23.1%
1
   7.7%
2
   8.0%
6
  20.7%
14
  12.8%
White
11
  73.3%
10
  71.4%
7
  53.8%
8
  61.5%
14
  56.0%
16
  55.2%
66
  60.6%
More than one race
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
Unknown or Not Reported
2
  13.3%
1
   7.1%
2
  15.4%
2
  15.4%
6
  24.0%
5
  17.2%
18
  16.5%
1.Primary Outcome
Title Objective Response (Non-Osteosarcoma Strata)
Hide Description Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders (Overall Best Response of Partial Response or Complete Response), and confidence intervals will be constructed accounting for the two-stage design.
Time Frame Up to the first 6 cycles of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in non-osteosarcoma strata which were either statistical strata (Ewing's Sarcoma, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, and Rare Tumors) or accrued enough patients to be analyzed (Wilms Tumor). Data is limited for Rare tumors due to low accrual.
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 13 13 13 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
0
(0.0 to 24.71)
0
(0.0 to 24.71)
0
(0.0 to 24.71)
0
(0.0 to 24.71)
13.04
(2.78 to 33.59)
2.Primary Outcome
Title Objective Response (Osteosarcoma Stratum)
Hide Description Will be assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 and Disease Control (see section 9.3.2 of the ADVL1622 Protocol). Response + Disease Control rate will be calculated as the percent of evaluable patients who are responders or who met the definition of disease control, and confidence intervals will be constructed accounting for the two-stage design.
Time Frame Up to the first 6 cycles of therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol in the osteosarcoma stratum.
Arm/Group Title Osteosarcoma
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
35.18
(20.16 to 48.27)
3.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
Time Frame Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who met the evaluable for toxicity criteria outlined in section 9.5 of the ADVL1622 protocol.
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 13 13 13 23 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
61.54
(31.58 to 86.14)
38.46
(13.86 to 68.42)
61.54
(31.58 to 86.14)
38.46
(13.86 to 68.42)
60.87
(38.54 to 80.29)
68.97
(49.17 to 84.72)
4.Secondary Outcome
Title Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Cmax
Hide Description Day 1 PK peak concentration will be summarized by the mean and the standard deviation.
Time Frame Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
Arm/Group Title All Pharmacokinetic Patients
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
567  (379.0)
5.Secondary Outcome
Title Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Tmax
Hide Description Day 1 PK time to peak concentration will be summarized by the mean and the standard deviation.
Time Frame Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
Arm/Group Title All Pharmacokinetic Patients
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Hour
2.9  (1.0)
6.Secondary Outcome
Title Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC
Hide Description Day 1 PK area under the curve will be summarized by the mean and the standard deviation.
Time Frame Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
Arm/Group Title All Pharmacokinetic Patients
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
7934  (4267.0)
7.Secondary Outcome
Title Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Accumulation
Hide Description PK accumulation will be summarized by the mean and the standard deviation.
Time Frame Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
Arm/Group Title All Pharmacokinetic Patients
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Ratio
6.6  (6.0)
8.Secondary Outcome
Title Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Half-life
Hide Description PK half-life will be summarized by the mean and the standard deviation.
Time Frame Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who consented to PK or were required to consent to PK and had enough samples to estimate the PK Parameter of interest.
Arm/Group Title All Pharmacokinetic Patients
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Hour
101  (100.1)
9.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Percent of patients not yet progressed at 1 year as estimated by the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as a >=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was also counted as an event for this analysis.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol.
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 13 13 13 23 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
16.78
(2.67 to 41.51)
0
(0 to 0)
15.39
(2.48 to 38.78)
23.08
(5.58 to 47.46)
20.6
(5.89 to 41.42)
21.25
(7.64 to 39.35)
10.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description The 1-year Progression Free Survival will be estimated using Kaplan-Meier methodology. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as a >=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol.
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 13 13 13 23 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
15.39
(2.48 to 38.78)
0
(0 to 0)
15.39
(2.48 to 38.78)
23.08
(5.58 to 47.46)
13.04
(3.27 to 29.72)
14.71
(4.66 to 30.19)
11.Secondary Outcome
Title Overall Survival (OS)
Hide Description The 1-year Overall Survival will be estimated using Kaplan-Meier methodology.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1622 protocol.
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Hide Arm/Group Description:
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 13 13 13 23 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
53.85
(24.77 to 75.99)
25
(6.01 to 50.48)
74.59
(39.76 to 91.10)
42.74
(15.90 to 67.50)
34.78
(16.63 to 53.71)
35.86
(18.96 to 53.13)
12.Other Pre-specified Outcome
Title Change in Immune Biomarkers
Hide Description The association between the host immune system and response to cabozantinib-s-malate will be assessed in an exploratory manner. each biomarker will be correlated with the clinical outcomes of objective response and progression free survival.
Time Frame Baseline, day 1 (prior to dose) of cycles 2 and 3
Outcome Measure Data Not Reported
Time Frame From start of treatment to 30 days after last dose, a median of 3.4 months
Adverse Event Reporting Description Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
 
Arm/Group Title Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Hide Arm/Group Description Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/13 (92.31%)   10/13 (76.92%)   8/13 (61.54%)   10/13 (76.92%)   18/23 (78.26%)   20/29 (68.97%) 
Hide Serious Adverse Events
Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/13 (46.15%)   2/13 (15.38%)   4/13 (30.77%)   6/13 (46.15%)   10/23 (43.48%)   8/29 (27.59%) 
Blood and lymphatic system disorders             
Anemia †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Cardiac disorders             
Heart failure †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Pericardial effusion †  2/13 (15.38%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Pericardial tamponade †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Left ventricular systolic dysfunction †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders             
Abdominal pain †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/23 (8.70%)  0/29 (0.00%) 
Colitis †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Constipation †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/23 (4.35%)  0/29 (0.00%) 
Esophageal stenosis †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Gastrointestinal disorders - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Ileus †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Nausea †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Oral pain †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Vomiting †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  2/23 (8.70%)  0/29 (0.00%) 
General disorders             
Death NOS †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Edema face †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Fatigue †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Fever †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/23 (4.35%)  0/29 (0.00%) 
Disease progression †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  2/23 (8.70%)  0/29 (0.00%) 
Localized edema †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Non-cardiac chest pain †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Infections and infestations             
Eye infection †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Infections and infestations - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  0/23 (0.00%)  0/29 (0.00%) 
Sepsis †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Skin infection †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Lung infection †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  2/23 (8.70%)  0/29 (0.00%) 
Injury, poisoning and procedural complications             
Wound dehiscence †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Investigations             
Alanine aminotransferase increased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/23 (8.70%)  0/29 (0.00%) 
Alkaline phosphatase increased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Aspartate aminotransferase increased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  3/23 (13.04%)  0/29 (0.00%) 
Blood bilirubin increased †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/23 (8.70%)  0/29 (0.00%) 
Investigations - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Weight loss †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  1/29 (3.45%) 
Ejection fraction decreased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Metabolism and nutrition disorders             
Anorexia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Dehydration †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  2/23 (8.70%)  0/29 (0.00%) 
Hyponatremia †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Hypophosphatemia †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Metabolism and nutrition disorders - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders             
Chest wall pain †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Flank pain †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/23 (8.70%)  0/29 (0.00%) 
Muscle weakness lower limb †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tumor pain †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  1/29 (3.45%) 
Leukemia secondary to oncology chemotherapy †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Nervous system disorders             
Dysarthria †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Headache †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Intracranial hemorrhage †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Nervous system disorders - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Paresthesia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Seizure †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Stroke †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Dysesthesia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnea †  0/13 (0.00%)  1/13 (7.69%)  1/13 (7.69%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Hypoxia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  3/13 (23.08%)  0/23 (0.00%)  0/29 (0.00%) 
Pleural effusion †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/23 (4.35%)  0/29 (0.00%) 
Pleuritic pain †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Pneumothorax †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/13 (7.69%)  0/23 (0.00%)  2/29 (6.90%) 
Productive cough †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Respiratory failure †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Rhinorrhea †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Sore throat †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Vascular disorders             
Hypotension †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/23 (4.35%)  0/29 (0.00%) 
Thromboembolic event †  0/13 (0.00%)  1/13 (7.69%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ewing's Sarcoma Rhabdomyosarcoma Non-Rhabdomyosarcoma Soft Tissue Sarcoma Wilms Tumor Rare Tumors Osteosarcoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/13 (38.46%)   7/13 (53.85%)   7/13 (53.85%)   7/13 (53.85%)   13/23 (56.52%)   17/29 (58.62%) 
Blood and lymphatic system disorders             
Anemia †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  1/13 (7.69%)  3/23 (13.04%)  0/29 (0.00%) 
Cardiac disorders             
Chest pain - cardiac †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Gastrointestinal disorders             
Abdominal pain †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Diarrhea †  2/13 (15.38%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Mucositis oral †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Nausea †  0/13 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  1/13 (7.69%)  0/23 (0.00%)  1/29 (3.45%) 
Pancreatitis †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Vomiting †  0/13 (0.00%)  1/13 (7.69%)  2/13 (15.38%)  0/13 (0.00%)  1/23 (4.35%)  1/29 (3.45%) 
General disorders             
Fatigue †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/13 (7.69%)  0/23 (0.00%)  1/29 (3.45%) 
Gait disturbance †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Pain †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Infections and infestations             
Upper respiratory infection †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Injury, poisoning and procedural complications             
Wound dehiscence †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  2/29 (6.90%) 
Investigations             
Alanine aminotransferase increased †  0/13 (0.00%)  1/13 (7.69%)  2/13 (15.38%)  0/13 (0.00%)  3/23 (13.04%)  1/29 (3.45%) 
Alkaline phosphatase increased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Aspartate aminotransferase increased †  1/13 (7.69%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  3/23 (13.04%)  3/29 (10.34%) 
Blood bilirubin increased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Lipase increased †  1/13 (7.69%)  2/13 (15.38%)  4/13 (30.77%)  1/13 (7.69%)  0/23 (0.00%)  2/29 (6.90%) 
Lymphocyte count decreased †  1/13 (7.69%)  1/13 (7.69%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Neutrophil count decreased †  3/13 (23.08%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  4/23 (17.39%)  2/29 (6.90%) 
Platelet count decreased †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  1/23 (4.35%)  0/29 (0.00%) 
Serum amylase increased †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Weight loss †  0/13 (0.00%)  1/13 (7.69%)  2/13 (15.38%)  1/13 (7.69%)  0/23 (0.00%)  1/29 (3.45%) 
White blood cell decreased †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/23 (4.35%)  1/29 (3.45%) 
GGT increased †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Urine output decreased †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Metabolism and nutrition disorders             
Anorexia †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Dehydration †  0/13 (0.00%)  1/13 (7.69%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Hypernatremia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Hypocalcemia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Hypokalemia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  2/29 (6.90%) 
Hyponatremia †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Hypophosphatemia †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  1/29 (3.45%) 
Musculoskeletal and connective tissue disorders             
Back pain †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Pain in extremity †  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  2/29 (6.90%) 
Nervous system disorders             
Dysarthria †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Nervous system disorders - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Syncope †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  0/29 (0.00%) 
Renal and urinary disorders             
Proteinuria †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Atelectasis †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/23 (0.00%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders             
Skin and subcutaneous tissue disorders - Other, specify †  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/23 (0.00%)  1/29 (3.45%) 
Palmar-plantar erythrodysesthesia syndrome †  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/23 (4.35%)  1/29 (3.45%) 
Vascular disorders             
Hypertension †  0/13 (0.00%)  2/13 (15.38%)  1/13 (7.69%)  0/13 (0.00%)  3/23 (13.04%)  2/29 (6.90%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 16264470064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02867592    
Other Study ID Numbers: NCI-2016-01258
NCI-2016-01258 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ADVL1622
ADVL1622 ( Other Identifier: Children's Oncology Group )
ADVL1622 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: August 15, 2016
First Posted: August 16, 2016
Results First Submitted: August 11, 2022
Results First Posted: November 28, 2022
Last Update Posted: May 20, 2024