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OLAParib COmbinations (OLAPCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576444
Recruitment Status : Terminated (The study was paused during COVID and without the ability to initiate the 4th arm in the study, the decision was to terminate the study in 2022.)
First Posted : October 15, 2015
Results First Posted : December 28, 2022
Last Update Posted : December 28, 2022
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Vanderbilt-Ingram Cancer Center
The Cleveland Clinic
Information provided by (Responsible Party):
Joseph Paul Eder, Yale University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: AZD2281
Drug: AZD5363
Drug: AZD1775
Drug: AZD6738
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738 Olaparib & Adavosertib AZD1775
Hide Arm/Group Description

Patients with cholangiocarcinoma harboring IDH 1/2 tumors will be treated with olaparib. Patients with tumors harboring mutation in HDR genes will be treated with olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

Patients with tumors harboring PTEN, PIK3CA, AKT, or ARID1A mutations or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway will be treated with AZD5363 plus olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD5363: Patients will be administered AZD5363 at 640 mg twice daily for two days on/five days off (2/7) schedule. Two (2) 200 mg tablets and three (3) 80 mg tablets should be taken twice daily.

Patients with tumors harboring either TP53 or KRAS mutations or mutations in KRAS and TP53 will be treated with AZD1775 plus olaparib. TP53 mutations must be found on the TP53 mutation eligibility list.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD1775: The recommended dose will be available no earlier than March 2016.

Patients with tumors harboring mutations in HDR genes, including ATM, CHK2, APOBEC, MRE11 complex, will be treated with AZD6738 and olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD6738: Patients will be administered AZD6738 at 160 mg daily for days 1-7 of a 28-day cycle (7/28) schedule. AZD6738 is available as 100, 20, and 10 mg tablets. Tablets should be taken daily.
Period Title: Overall Study
Started 26 16 25 0
Completed 25 15 21 0
Not Completed 1 1 4 0
Reason Not Completed
Death             1             1             0             0
Withdrawal by Subject             0             0             2             0
Adverse Event             0             0             1             0
Physician Decision             0             0             1             0
Arm/Group Title Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738 Olaparib & Adavosertib AZD1775 Total
Hide Arm/Group Description

Patients with cholangiocarcinoma harboring IDH 1/2 tumors will be treated with olaparib. Patients with tumors harboring mutation in HDR genes will be treated with olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

Patients with tumors harboring PTEN, PIK3CA, AKT, or ARID1A mutations or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway will be treated with AZD5363 plus olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD5363: Patients will be administered AZD5363 at 640 mg twice daily for two days on/five days off (2/7) schedule. Two (2) 200 mg tablets and three (3) 80 mg tablets should be taken twice daily.

Patients with tumors harboring either TP53 or KRAS mutations or mutations in KRAS and TP53 will be treated with AZD1775 plus olaparib. TP53 mutations must be found on the TP53 mutation eligibility list.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD1775: The recommended dose will be available no earlier than March 2016.

Patients with tumors harboring mutations in HDR genes, including ATM, CHK2, APOBEC, MRE11 complex, will be treated with AZD6738 and olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD6738: Patients will be administered AZD6738 at 160 mg daily for days 1-7 of a 28-day cycle (7/28) schedule. AZD6738 is available as 100, 20, and 10 mg tablets. Tablets should be taken daily.

 Total of all reporting groups
Overall Number of Baseline Participants 26 16 25 0 67
Hide Baseline Analysis Population Description
Arm 4 (Olaparib & Adavosertib AZD1775) was never activated following the study pause due to COVID.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 16 participants 25 participants 0 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
Between 18 and 65 years
17
  65.4%
11
  68.8%
19
  76.0%
 0
47
  70.1%
>=65 years
9
  34.6%
5
  31.3%
6
  24.0%
 0
20
  29.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 16 participants 25 participants 0 participants 67 participants
Female
8
  30.8%
12
  75.0%
18
  72.0%
 0
38
  56.7%
Male
18
  69.2%
4
  25.0%
7
  28.0%
 0
29
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 16 participants 25 participants 0 participants 67 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   4.0%
 0
1
   1.5%
Not Hispanic or Latino
18
  69.2%
13
  81.3%
19
  76.0%
 0
50
  74.6%
Unknown or Not Reported
8
  30.8%
3
  18.8%
5
  20.0%
 0
16
  23.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 16 participants 25 participants 0 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   4.0%
 0
1
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
Black or African American
1
   3.8%
0
   0.0%
1
   4.0%
 0
2
   3.0%
White
18
  69.2%
12
  75.0%
19
  76.0%
 0
49
  73.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
 0
0
   0.0%
Unknown or Not Reported
7
  26.9%
4
  25.0%
4
  16.0%
 0
15
  22.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 16 participants 25 participants 0 participants 67 participants
26 16 25 68
1.Primary Outcome
Title Overall Response Rate
Hide Description Tumor overall response rate (ORR) in molecularly selected patients with measurable disease as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment across tumor types in each arm of the study (Note: there will be no formal comparison between arms). Complete Response (CR): disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Clinical Benefit is defined as the sum of CR, PR, or SD at 16 weeks from the start of treatment.
Time Frame Change from baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients not included due to death: 1 from Olaparib AZD2881, 1 from Olaparib & Capivasertib AZD5363. The Olaparib & Adavosertib AZD1775 arm was never initiated. One participant in Olaparib & Ceralasertib AZD6738 arm not included because taken off study by physician decision and 2 subjects withdrew.
Arm/Group Title Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738 Olaparib & Adavosertib AZD1775
Hide Arm/Group Description:

Patients with cholangiocarcinoma harboring IDH 1/2 tumors will be treated with olaparib. Patients with tumors harboring mutation in HDR genes will be treated with olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

Patients with tumors harboring PTEN, PIK3CA, AKT, or ARID1A mutations or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway will be treated with AZD5363 plus olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD5363: Patients will be administered AZD5363 at 640 mg twice daily for two days on/five days off (2/7) schedule. Two (2) 200 mg tablets and three (3) 80 mg tablets should be taken twice daily.

Patients with tumors harboring either TP53 or KRAS mutations or mutations in KRAS and TP53 will be treated with AZD1775 plus olaparib. TP53 mutations must be found on the TP53 mutation eligibility list.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD1775: The recommended dose will be available no earlier than March 2016.

Patients with tumors harboring mutations in HDR genes, including ATM, CHK2, APOBEC, MRE11 complex, will be treated with AZD6738 and olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD6738: Patients will be administered AZD6738 at 160 mg daily for days 1-7 of a 28-day cycle (7/28) schedule. AZD6738 is available as 100, 20, and 10 mg tablets. Tablets should be taken daily.
Overall Number of Participants Analyzed 25 15 24 0
Measure Type: Count of Participants
Unit of Measure: Participants
CR = complete response
0
   0.0%
0
   0.0%
0
   0.0%
 0
PR = partial response
2
   8.0%
1
   6.7%
2
   8.3%
 0
SD = stable disease
7
  28.0%
5
  33.3%
13
  54.2%
 0
PD = progressive disease
16
  64.0%
9
  60.0%
9
  37.5%
 0
Time Frame Up to 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738
Hide Arm/Group Description

Patients with cholangiocarcinoma harboring IDH 1/2 tumors will be treated with olaparib. Patients with tumors harboring mutation in HDR genes will be treated with olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

Patients with tumors harboring PTEN, PIK3CA, AKT, or ARID1A mutations or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway will be treated with AZD5363 plus olaparib.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD5363: Patients will be administered AZD5363 at 640 mg twice daily for two days on/five days off (2/7) schedule. Two (2) 200 mg tablets and three (3) 80 mg tablets should be taken twice daily.

Patients with tumors harboring either TP53 or KRAS mutations or mutations in KRAS and TP53 will be treated with AZD1775 plus olaparib. TP53 mutations must be found on the TP53 mutation eligibility list.

AZD2281: Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

AZD1775: The recommended dose will be available no earlier than March 2016.
All-Cause Mortality
Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/26 (3.85%)      1/16 (6.25%)      0/25 (0.00%)    
Hide Serious Adverse Events
Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/26 (38.46%)      9/16 (56.25%)      17/25 (68.00%)    
Blood and lymphatic system disorders       
Anemia †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Blood and lymphatic system disorders - Other †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Cardiac disorders       
Sinus bradycardia †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders       
Abdominal pain †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Duodenal obstruction †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Nausea †  0/26 (0.00%)  0 1/16 (6.25%)  1 1/25 (4.00%)  1
Rectal pain †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Ascites †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Colitis †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  2
Gastrointestinal disorders - Other †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Vomiting †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
General disorders       
Non-cardiac chest pain †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Gallbladder pain †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Hepatobiliary disorders - Other †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Infections and infestations       
Infections and infestations - Other †  1/26 (3.85%)  2 0/16 (0.00%)  0 1/25 (4.00%)  1
Injury, poisoning and procedural complications       
Hip fracture †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Vascular access complication †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Metabolism and nutrition disorders       
Dehydration †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders       
Back pain †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Nervous system disorders       
Dizziness †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Seizure †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Syncope †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Psychiatric disorders       
Confusion †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Psychosis †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Renal and urinary disorders       
Urinary retention †  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Acute kidney injury †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Hematuria †  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea †  1/26 (3.85%)  1 1/16 (6.25%)  1 1/25 (4.00%)  2
Aspiration †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other †  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olaparib AZD2881 Olaparib & Capivasertib AZD5363 Olaparib & Ceralasertib AZD6738
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/26 (65.38%)      3/16 (18.75%)      17/25 (68.00%)    
Blood and lymphatic system disorders       
Anemia * 1  9/26 (34.62%)  21 2/16 (12.50%)  3 11/25 (44.00%)  25
Blood and lymphatic system disorders - Other * 1  4/26 (15.38%)  5 0/16 (0.00%)  0 8/25 (32.00%)  33
Leukocytosis * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Cardiac disorders       
Chest pain - cardiac * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Endocrine disorders       
Adrenal insufficiency * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Eye disorders       
Blurred vision * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Retinal vascular disorder * 1  1/26 (3.85%)  2 0/16 (0.00%)  0 0/25 (0.00%)  0
Gastrointestinal disorders       
Nausea * 1  6/26 (23.08%)  9 2/16 (12.50%)  4 8/25 (32.00%)  8
Vomiting * 1  3/26 (11.54%)  5 2/16 (12.50%)  3 6/25 (24.00%)  6
Diarrhea * 1  2/26 (7.69%)  2 3/16 (18.75%)  4 2/25 (8.00%)  2
Constipation * 1  2/26 (7.69%)  2 0/16 (0.00%)  0 3/25 (12.00%)  3
Abdominal pain * 1  1/26 (3.85%)  2 0/16 (0.00%)  0 1/25 (4.00%)  1
Dyspepsia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 2/25 (8.00%)  2
Abdominal distension * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Bloating * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Dysphagia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Gastritis * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Gastroesophageal reflux disease * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Gastrointestinal disorders - Other * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Fatigue * 1  3/26 (11.54%)  5 1/16 (6.25%)  1 6/25 (24.00%)  7
Fever * 1  2/26 (7.69%)  2 0/16 (0.00%)  0 1/25 (4.00%)  1
General disorders and administration site conditions - Other * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 3/25 (12.00%)  7
Pain * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 2/25 (8.00%)  2
Chills * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Edema limbs * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Flu like symptoms * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Malaise * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Non-cardiac chest pain * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Immune system disorders       
Immune system disorders - Other * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 1/25 (4.00%)  1
Infections and infestations       
Mucosal infection * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Papulopustular rash * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Upper respiratory infection * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  2
Urinary tract infection * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  2
Injury, poisoning and procedural complications       
Injury, poisoning and procedural complications - Other * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Investigations       
Alanine aminotransferase increased * 1  2/26 (7.69%)  4 1/16 (6.25%)  1 1/25 (4.00%)  1
Creatinine increased * 1  2/26 (7.69%)  2 0/16 (0.00%)  0 2/25 (8.00%)  2
Aspartate aminotransferase increased * 1  2/26 (7.69%)  3 0/16 (0.00%)  0 1/25 (4.00%)  2
White blood cell decreased * 1  1/26 (3.85%)  2 0/16 (0.00%)  0 2/25 (8.00%)  2
Alkaline phosphatase increased * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 1/25 (4.00%)  1
GGT increased * 1  2/26 (7.69%)  3 0/16 (0.00%)  0 0/25 (0.00%)  0
Neutrophil count decreased * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 1/25 (4.00%)  1
Investigations - Other * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Lymphocyte count increased * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Platelet count decreased * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  2
Weight loss * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia * 1  2/26 (7.69%)  2 0/16 (0.00%)  0 1/25 (4.00%)  1
Hyperglycemia * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 2/25 (8.00%)  3
Hypokalemia * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 2/25 (8.00%)  3
Dehydration * 1  1/26 (3.85%)  2 1/16 (6.25%)  1 0/25 (0.00%)  0
Hypocalcemia * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 1/25 (4.00%)  1
Hypercalcemia * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Hypermagnesemia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Hypoalbuminemia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  2
Hyponatremia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Metabolism and nutrition disorders - Other * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorder - Other * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 2/25 (8.00%)  2
Back pain * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Flank pain * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Generalized muscle weakness * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Neck pain * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain * 1  1/26 (3.85%)  2 0/16 (0.00%)  0 0/25 (0.00%)  0
Nervous system disorders       
Dizziness * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 3/25 (12.00%)  5
Headache * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 2/25 (8.00%)  2
Peripheral sensory neuropathy * 1  2/26 (7.69%)  2 0/16 (0.00%)  0 0/25 (0.00%)  0
Dysarthria * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Dysgeusia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Seizure * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Psychiatric disorders       
Anxiety * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Depression * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Renal and urinary disorders       
Hematuria * 1  2/26 (7.69%)  2 0/16 (0.00%)  0 1/25 (4.00%)  2
Proteinuria * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 1/25 (4.00%)  2
Urine discoloration * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea * 1  3/26 (11.54%)  3 1/16 (6.25%)  1 3/25 (12.00%)  6
Cough * 1  0/26 (0.00%)  0 2/16 (12.50%)  4 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders - Other * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 2/25 (8.00%)  2
Laryngeal mucositis * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Nasal congestion * 1  1/26 (3.85%)  1 0/16 (0.00%)  0 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Hyperhidrosis * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
Rash maculo-papular * 1  0/26 (0.00%)  0 1/16 (6.25%)  1 0/25 (0.00%)  0
Vascular disorders       
Hypotension * 1  0/26 (0.00%)  0 0/16 (0.00%)  0 1/25 (4.00%)  1
1
Term from vocabulary, CTCAE
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph Paul Eder, MD
Organization: Yale School of Medicine: Medical Oncology
Phone: (203) 737-6980
EMail: joseph.eder@yale.edu
Layout table for additonal information
Responsible Party: Joseph Paul Eder, Yale University
ClinicalTrials.gov Identifier: NCT02576444    
Other Study ID Numbers: 1508016363
First Submitted: October 12, 2015
First Posted: October 15, 2015
Results First Submitted: August 25, 2022
Results First Posted: December 28, 2022
Last Update Posted: December 28, 2022