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Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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: NCT02101775
Recruitment Status : Active, not recruiting
First Posted : April 2, 2014
Results First Posted : September 8, 2023
Last Update Posted : March 8, 2024
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Ovarian Brenner Tumor
Ovarian Carcinosarcoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Serous Surface Papillary Adenocarcinoma
Ovarian Undifferentiated Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Drug: Adavosertib
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo Administration
Other: Questionnaire Administration
Enrollment 124
Recruitment Details Between Oct. 16, 2014 and Jan. 16, 2018, 124 women were enrolled, of whom 99 had high-grade serous ovarian cancer and were randomly assigned to AZD1775 plus gemcitabine (65 [66%]) or placebo plus gemcitabine (34 [34%]). 25 women with non-high-grade serous ovarian cancer were enrolled in the exploratory cohort.
Pre-assignment Details After randomization, five patients with high-grade serous ovarian cancer were found to be ineligible (four in the experimental group and one in the control group) and did not receive treatment.
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory Cohort)
Hide Arm/Group Description Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-high-grade serous ovarian cancer. Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 65 34 25
Completed 61 33 25
Not Completed 4 1 0
Reason Not Completed
Adverse Event             4             0             0
Admission to Hospital             0             1             0
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Total
Hide Arm/Group Description Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 61 33 25 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 33 participants 25 participants 119 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
  68.9%
21
  63.6%
20
  80.0%
83
  69.7%
>=65 years
19
  31.1%
12
  36.4%
5
  20.0%
36
  30.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants 33 participants 25 participants 119 participants
62
(45 to 75)
63
(43 to 76)
58
(33 to 76)
62
(33 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 33 participants 25 participants 119 participants
Female
61
 100.0%
33
 100.0%
25
 100.0%
119
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 33 participants 25 participants 119 participants
American Indian or Alaska Native
2
   3.3%
0
   0.0%
1
   4.0%
3
   2.5%
Asian
8
  13.1%
2
   6.1%
7
  28.0%
17
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.6%
3
   9.1%
1
   4.0%
5
   4.2%
White
48
  78.7%
27
  81.8%
16
  64.0%
91
  76.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.3%
1
   3.0%
0
   0.0%
3
   2.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 61 participants 33 participants 25 participants 119 participants
Canada
38
  62.3%
25
  75.8%
12
  48.0%
75
  63.0%
United States
23
  37.7%
8
  24.2%
13
  52.0%
44
  37.0%
1.Primary Outcome
Title Progression Free Survival
Hide Description To evaluate the progression free survival (PFS) of subjects with recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer receiving gemcitabine in combination with AZD1775 compared to subjects receiving gemcitabine in combination with placebo. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guideline, as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.
Time Frame From start of treatment until date of progression or death, whichever occurs first, up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 61 33 25
Median (95% Confidence Interval)
Unit of Measure: months
4.6
(3.6 to 6.4)
3.0
(1.8 to 3.8)
5.3
(1.6 to 7.7)
2.Secondary Outcome
Title Objective Response
Hide Description To evaluate the objective response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. RECIST v1.1 criteria used for evaluation of target lesions: 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; Progressive Disease (PD), at least a 20% increase 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 PD. The Best Overall Response is the best response recorded from the start of the treatment until disease progression/recurrence .
Time Frame From start of treatment, every 6-8 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 61 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
14
  23.0%
2
   6.1%
3
  12.0%
3.Secondary Outcome
Title Response According to CA125 Criteria
Hide Description To evaluate the GCIG CA125 response rate of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo. A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample. The response must be confirmed and maintained for at least 28 days.
Time Frame From start of treatment, every 4 weeks, until time of progression or death, whichever occurs first, up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 61 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
14
  23.0%
3
   9.1%
4
  16.0%
4.Secondary Outcome
Title Overall Survival
Hide Description To evaluate the overall survival of patients receiving gemcitabine combined with AZD1775 compared to patients receiving gemcitabine in combination with placebo.
Time Frame From start of study treatment, every 12 weeks, until death, up to 22 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 61 33 25
Median (95% Confidence Interval)
Unit of Measure: months
11.4
(8.2 to 16.5)
7.2
(5.2 to 13.2)
13
(8.5 to 21.7)
5.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Adverse Events Related to Study Treatment
Hide Description To evaluate the safety and tolerability of the combination of gemcitabine combined with AZD1775 in patients with recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.
Time Frame From start of treatment until AE resolution, stabilization, or improvement to less than grade 2, up to 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 61 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenia
38
  62.3%
10
  30.3%
18
  72.0%
Thrombocytopenia
19
  31.1%
2
   6.1%
9
  36.0%
Fatigue
10
  16.4%
3
   9.1%
4
  16.0%
Anemia
19
  31.1%
6
  18.2%
8
  32.0%
Decreased White Blood Cell Count
33
  54.1%
6
  18.2%
16
  64.0%
Decreased Lymphocyte Count
21
  34.4%
6
  18.2%
9
  36.0%
Febrile Neutropenia
7
  11.5%
0
   0.0%
2
   8.0%
Abdominal Pain
1
   1.6%
1
   3.0%
0
   0.0%
Nausea
2
   3.3%
1
   3.0%
0
   0.0%
Vomiting
1
   1.6%
2
   6.1%
0
   0.0%
Edema Trunk
2
   3.3%
0
   0.0%
0
   0.0%
Catheter Related Infection
0
   0.0%
1
   3.0%
0
   0.0%
Sepsis
3
   4.9%
0
   0.0%
0
   0.0%
Skin Infection
0
   0.0%
1
   3.0%
0
   0.0%
Urinary Tract Infection
4
   6.6%
0
   0.0%
0
   0.0%
Weight Gain
1
   1.6%
0
   0.0%
0
   0.0%
Dehydration
1
   1.6%
1
   3.0%
2
   8.0%
Hypokalemia
6
   9.8%
0
   0.0%
2
   8.0%
Hyponatremia
0
   0.0%
1
   3.0%
0
   0.0%
Hypophosphatemia
3
   4.9%
0
   0.0%
2
   8.0%
Dyspnea
3
   4.9%
0
   0.0%
0
   0.0%
Pneumonitis
1
   1.6%
0
   0.0%
0
   0.0%
Hypertension
1
   1.6%
0
   0.0%
0
   0.0%
Thromboembolic Event
2
   3.3%
1
   3.0%
0
   0.0%
Alanine Aminotransferase Increased
2
   3.3%
2
   6.1%
0
   0.0%
Aspartate Aminotransferase Increased
3
   4.9%
3
   9.1%
0
   0.0%
Diarrhea
1
   1.6%
0
   0.0%
1
   4.0%
Rash Maculo-Papular
4
   6.6%
0
   0.0%
0
   0.0%
Hypoalbuminemia
1
   1.6%
0
   0.0%
0
   0.0%
Alkaline Phosphatase Increased
1
   1.6%
0
   0.0%
0
   0.0%
Pruritis
1
   1.6%
0
   0.0%
0
   0.0%
Headache
1
   1.6%
0
   0.0%
0
   0.0%
Syncope
1
   1.6%
0
   0.0%
0
   0.0%
Anaphylaxis
1
   1.6%
0
   0.0%
0
   0.0%
Atrial Fibrillation
1
   1.6%
0
   0.0%
0
   0.0%
Pneumonia
1
   1.6%
1
   3.0%
0
   0.0%
Hematoma
0
   0.0%
1
   3.0%
0
   0.0%
Wound Complication
0
   0.0%
1
   3.0%
0
   0.0%
Fever
0
   0.0%
0
   0.0%
1
   4.0%
Enterocolitis Infection
0
   0.0%
0
   0.0%
1
   4.0%
Lung Infection
0
   0.0%
0
   0.0%
1
   4.0%
6.Secondary Outcome
Title TP53 Mutations
Hide Description To evaluate TP53 mutations (presence of mutation and type of mutation) as potential predictive factors of benefit (defined as response or PFS prolongation) to AZD1775 and gemcitabine treatment. TP53 status was assessed using Sanger sequencing.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
TP53 status was assessed in 108 patients. 8 patients had insufficient or unavailable samples and 3 patients were not tested.
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 56 33 19
Measure Type: Count of Participants
Unit of Measure: Participants
48
  85.7%
22
  66.7%
8
  42.1%
7.Secondary Outcome
Title p53 Protein Expression
Hide Description

To evaluate p53 protein expression by immunohistochemistry as potential predictive factors of benefit (defined as response or PFS prolongation) to AZD1775 and gemcitabine treatment.

Evaluating p53 expression in patients with high-grade serous ovarian cancer and in patients with high-grade serous ovarian cancer with TP53 mutations.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
As per protocol, p53 protein expression was evaluated by immunohistochemistry to correlate with patients' mutational status of TP53
Arm/Group Title Abnormal p53 Expression in Patients With High-grade Serous Ovarian Cancer Abnormal p53 Expression in Patients With High-grade Serous Ovarian Cancer and With TP53 Mutations
Hide Arm/Group Description:
Abnormal p53 expression in patients with high-grade serous ovarian cancer
Abnormal p53 expression in patients with high-grade serous ovarian cancer and with TP53 mutations
Overall Number of Participants Analyzed 88 70
Measure Type: Count of Participants
Unit of Measure: Participants
82
  93.2%
68
  97.1%
8.Other Pre-specified Outcome
Title Patient Reported Outcomes
Hide Description

Will be assessed using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Each symptomatic AE is assessed with respect to 1 to 3 of the following attributes: frequency (F), severity (S) and/or interference (I) with usual or daily activities, and a recall period of 'the past 7 days'. PRO-CTCAE responses are scored from 0 to 4 with scores of 3 and 4 corresponding to high frequency, severity and/or interference. Results show the number of patients in each arm reporting high scores (3-4) for symptomatic AEs occurring in >30% of patients
Time Frame First 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (WEE1 Inhibitor AZD-1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD-1775, Gemcitabine)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 28 19 8
Measure Type: Count of Participants
Unit of Measure: Participants
Abdominal Pain F
10
  35.7%
9
  47.4%
1
  12.5%
Abdominal Pain S
9
  32.1%
5
  26.3%
0
   0.0%
Anxiety F
7
  25.0%
6
  31.6%
2
  25.0%
Bloating F
10
  35.7%
5
  26.3%
1
  12.5%
Bloating S
9
  32.1%
3
  15.8%
1
  12.5%
Fatigue S
16
  57.1%
6
  31.6%
4
  50.0%
Fatigue I
17
  60.7%
7
  36.8%
5
  62.5%
9.Other Pre-specified Outcome
Title TP53 Mutations in Circulating Tumor Deoxyribonucleic Acid
Hide Description TP53 mutations in circulating tumor deoxyribonucleic acid will be evaluated by TAm-Seq.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Arm I (WEE1 Inhibitor AZD-1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD-1775, Gemcitabine)
Hide Arm/Group Description:
Patients receive WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Change in Levels of Circulating Deoxyribonucleic Acid TP53 Mutations by TAm-Seq
Hide Description

Levels of circulating deoxyribonucleic acid TP53 mutations will be correlated with response.

*No results for this outcome measure
Time Frame Baseline to up to 1 year
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Changes in pCDC2 in Skin and Tumor Tissue
Hide Description

Validation of pCDC2 as a pharmacodynamic marker of therapy.

*No results for this outcome measure
Time Frame Baseline and at day 2 or 9 (course 1)
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Changes in gH2AX in Skin and Tumor Tissue
Hide Description

Validation of gH2AX as a pharmacodynamic marker of therapy.

*No results for this outcome measure
Time Frame Baseline and at day 2 or 9 (course 1)
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Changes in pCDC2
Hide Description

Changes in pCDC2 will be correlated with survival outcomes and response rate.

*No results for this outcome measure
Time Frame Baseline and at day 2 or 9 (course 1)
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Changes in pH2AX
Hide Description

Changes in pH2AX will be correlated with survival outcomes and response rate.

*No results for this outcome measure
Time Frame Baseline and at day 2 or 9 (course 1)
Outcome Measure Data Not Reported
Time Frame Adverse Events monitored/assessed from start of treatment until AE resolution, up to 1 year follow-up. All-Cause Mortality monitored/assessed for up to 22 months.
Adverse Event Reporting Description Adverse events regularly assessed by Investigator
 
Arm/Group Title Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Hide Arm/Group Description Patients receive WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-high-grade serous histology were enrolled in an exploratory single-arm cohort and received WEE1 inhibitor AZD1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/61 (81.97%)      30/33 (90.91%)      16/25 (64.00%)    
Hide Serious Adverse Events
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/61 (47.54%)      12/33 (36.36%)      10/25 (40.00%)    
Blood and lymphatic system disorders       
Anemia †  3/61 (4.92%)  5 2/33 (6.06%)  3 1/25 (4.00%)  1
Febrile Neutropenia †  4/61 (6.56%)  5 0/33 (0.00%)  0 2/25 (8.00%)  2
Right Leg Deep Vein Thrombosis †  0/61 (0.00%)  0 1/33 (3.03%)  1 0/25 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain †  4/61 (6.56%)  4 2/33 (6.06%)  2 0/25 (0.00%)  0
Ascites †  1/61 (1.64%)  1 1/33 (3.03%)  1 0/25 (0.00%)  0
Colonic Obstruction †  2/61 (3.28%)  2 1/33 (3.03%)  1 0/25 (0.00%)  0
Constipation †  1/61 (1.64%)  1 1/33 (3.03%)  1 0/25 (0.00%)  0
Diarrhea †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Ileus †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Jejunal Obstruction †  0/61 (0.00%)  0 1/33 (3.03%)  1 0/25 (0.00%)  0
Nausea †  1/61 (1.64%)  1 1/33 (3.03%)  1 0/25 (0.00%)  0
Obstruction Gastric †  0/61 (0.00%)  0 1/33 (3.03%)  1 0/25 (0.00%)  0
Small Intestinal Obstruction †  4/61 (6.56%)  5 1/33 (3.03%)  1 2/25 (8.00%)  2
Vomiting †  1/61 (1.64%)  1 2/33 (6.06%)  2 0/25 (0.00%)  0
General disorders       
Edema Trunk †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Fatigue †  0/61 (0.00%)  0 0/33 (0.00%)  0 1/25 (4.00%)  1
Fever †  8/61 (13.11%)  9 0/33 (0.00%)  0 0/25 (0.00%)  0
Treatment Hypersensitivity †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Death Due to Disease Progression †  0/61 (0.00%)  1/33 (3.03%)  0/25 (0.00%) 
Infections and infestations       
Abdominal Infection †  2/61 (3.28%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
Appendicitis Perforated †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Catheter Related Infection †  0/61 (0.00%)  0 1/33 (3.03%)  1 0/25 (0.00%)  0
Sepsis †  3/61 (4.92%)  5 0/33 (0.00%)  0 0/25 (0.00%)  0
Skin Infection †  0/61 (0.00%)  0 1/33 (3.03%)  1 0/25 (0.00%)  0
Urinary Tract Infection †  4/61 (6.56%)  10 0/33 (0.00%)  0 1/25 (4.00%)  1
Cellulitis †  0/61 (0.00%)  0 1/33 (3.03%)  1 1/25 (4.00%)  1
Investigations       
Cardiac Troponin I Increased †  0/61 (0.00%)  0 0/33 (0.00%)  0 1/25 (4.00%)  1
Lymphocyte Count Decreased †  1/61 (1.64%)  1 1/33 (3.03%)  1 2/25 (8.00%)  2
Neutrophil Count Decreased †  7/61 (11.48%)  9 2/33 (6.06%)  2 3/25 (12.00%)  3
Platelet Count Decreased †  5/61 (8.20%)  7 0/33 (0.00%)  0 1/25 (4.00%)  1
Weight Gain †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
White Blood Cell Decreased †  6/61 (9.84%)  6 1/33 (3.03%)  1 2/25 (8.00%)  2
Metabolism and nutrition disorders       
Dehydration †  0/61 (0.00%)  0 1/33 (3.03%)  1 2/25 (8.00%)  2
Hypokalemia †  0/61 (0.00%)  0 0/33 (0.00%)  0 1/25 (4.00%)  1
Hypoatremia †  0/61 (0.00%)  0 0/33 (0.00%)  0 1/25 (4.00%)  1
Hypophosphatemia †  1/61 (1.64%)  1 0/33 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders       
Muscle Weakness Left-Sided †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Nervous system disorders       
Headache †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Renal and urinary disorders       
Urinary Tract Obstruction †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Reproductive system and breast disorders       
Pelvic Pain †  0/61 (0.00%)  0 0/33 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea †  2/61 (3.28%)  2 0/33 (0.00%)  0 0/25 (0.00%)  0
Pleural Effusion †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Pneumonitis †  2/61 (3.28%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
Vascular disorders       
Hypertension †  1/61 (1.64%)  1 0/33 (0.00%)  0 0/25 (0.00%)  0
Thromboembolic Event †  1/61 (1.64%)  1 1/33 (3.03%)  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 5%
Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) Arm II (Placebo, Gemcitabine Hydrochloride) Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/61 (100.00%)      33/33 (100.00%)      25/25 (100.00%)    
Blood and lymphatic system disorders       
Anemia †  54/61 (88.52%)  54 30/33 (90.91%)  30 25/25 (100.00%)  25
Febrile neutropenia †  10/61 (16.39%)  10 7/33 (21.21%)  7 5/25 (20.00%)  5
Leukocytosis †  0/61 (0.00%)  0 0/33 (0.00%)  0 2/25 (8.00%)  2
Cardiac disorders       
Palpitations †  8/61 (13.11%)  8 3/33 (9.09%)  3 0/25 (0.00%)  0
Sinus tachycardia †  6/61 (9.84%)  6 4/33 (12.12%)  4 2/25 (8.00%)  2
Ear and labyrinth disorders       
Tinnitus †  3/61 (4.92%)  3 2/33 (6.06%)  2 0/25 (0.00%)  0
Hearing impaired †  3/61 (4.92%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
Vertigo †  2/61 (3.28%)  2 0/33 (0.00%)  0 3/25 (12.00%)  3
Endocrine disorders       
Hypothyroidism †  3/61 (4.92%)  3 3/33 (9.09%)  3 5/25 (20.00%)  5
Eye disorders       
Blurred vision †  5/61 (8.20%)  5 4/33 (12.12%)  4 4/25 (16.00%)  4
Cataract †  3/61 (4.92%)  3 0/33 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders       
Nausea †  49/61 (80.33%)  49 24/33 (72.73%)  24 20/25 (80.00%)  20
Abdominal pain †  45/61 (73.77%)  45 22/33 (66.67%)  22 20/25 (80.00%)  20
Constipation †  43/61 (70.49%)  43 20/33 (60.61%)  20 20/25 (80.00%)  20
Diarrhea †  38/61 (62.30%)  38 14/33 (42.42%)  14 12/25 (48.00%)  12
Vomiting †  36/61 (59.02%)  36 10/33 (30.30%)  10 12/25 (48.00%)  12
Dyspepsia †  19/61 (31.15%)  19 10/33 (30.30%)  10 5/25 (20.00%)  5
Abdominal distension †  12/61 (19.67%)  12 13/33 (39.39%)  13 4/25 (16.00%)  4
Bloating †  12/61 (19.67%)  12 11/33 (33.33%)  11 7/25 (28.00%)  7
Oral mucositis †  15/61 (24.59%)  15 3/33 (9.09%)  3 3/25 (12.00%)  3
Ascites †  12/61 (19.67%)  12 9/33 (27.27%)  9 4/25 (16.00%)  4
Dry mouth †  9/61 (14.75%)  9 0/33 (0.00%)  0 0/25 (0.00%)  0
Gastroesophageal reflux disease †  8/61 (13.11%)  8 4/33 (12.12%)  4 5/25 (20.00%)  5
Hemorrhoids †  7/61 (11.48%)  7 0/33 (0.00%)  0 3/25 (12.00%)  3
Flatulence †  6/61 (9.84%)  6 1/33 (3.03%)  1 0/25 (0.00%)  0
Small intestinal obstruction †  5/61 (8.20%)  5 3/33 (9.09%)  3 2/25 (8.00%)  2
Dysphagia †  4/61 (6.56%)  4 0/33 (0.00%)  0 1/25 (4.00%)  1
Hemorrhoidal hemorrhage †  3/61 (4.92%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
General disorders       
Fatigue †  54/61 (88.52%)  54 32/33 (96.97%)  32 20/25 (80.00%)  20
Fever †  34/61 (55.74%)  34 14/33 (42.42%)  14 11/25 (44.00%)  11
Chills †  20/61 (32.79%)  20 10/33 (30.30%)  10 4/25 (16.00%)  4
Limb edema †  20/61 (32.79%)  20 12/33 (36.36%)  12 7/25 (28.00%)  7
Pain †  9/61 (14.75%)  9 0/33 (0.00%)  0 0/25 (0.00%)  0
Flu like symptoms †  6/61 (9.84%)  6 5/33 (15.15%)  5 4/25 (16.00%)  4
Non-cardiac chest pain †  4/61 (6.56%)  4 4/33 (12.12%)  4 2/25 (8.00%)  2
Malaise †  3/61 (4.92%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
Localized edema †  2/61 (3.28%)  2 2/33 (6.06%)  2 3/25 (12.00%)  3
Injection site reaction †  1/61 (1.64%)  1 0/33 (0.00%)  0 2/25 (8.00%)  2
Infections and infestations       
Urinary tract infection †  14/61 (22.95%)  14 3/33 (9.09%)  3 3/25 (12.00%)  3
Skin infection †  2/61 (3.28%)  2 6/33 (18.18%)  6 3/25 (12.00%)  3
Vaginal infection †  0/61 (0.00%)  0 0/33 (0.00%)  0 2/25 (8.00%)  2
Mucosal infection †  0/61 (0.00%)  0 0/33 (0.00%)  0 2/25 (8.00%)  2
Sinusitis †  0/61 (0.00%)  0 0/33 (0.00%)  0 2/25 (8.00%)  2
Injury, poisoning and procedural complications       
Bruising †  4/61 (6.56%)  4 1/33 (3.03%)  1 2/25 (8.00%)  2
Wound complication †  3/61 (4.92%)  3 1/33 (3.03%)  1 0/25 (0.00%)  0
Fall †  3/61 (4.92%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
Investigations       
Decreased white blood cell count †  54/61 (88.52%)  54 23/33 (69.70%)  23 24/25 (96.00%)  24
Decreased platelet count (thrombocytopenia) †  52/61 (85.25%)  52 22/33 (66.67%)  22 21/25 (84.00%)  21
Decreased neutrophil count (neutropenia) †  50/61 (81.97%)  50 22/33 (66.67%)  22 23/25 (92.00%)  23
Decreased lymphocyte count †  47/61 (77.05%)  47 22/33 (66.67%)  22 20/25 (80.00%)  20
Increased alanine aminotransferase †  39/61 (63.93%)  39 22/33 (66.67%)  22 14/25 (56.00%)  14
Increased aspartate aminotransferase †  38/61 (62.30%)  38 23/33 (69.70%)  23 14/25 (56.00%)  14
Weight loss †  19/61 (31.15%)  19 8/33 (24.24%)  8 4/25 (16.00%)  4
Increased alkaline phosphatase †  18/61 (29.51%)  18 11/33 (33.33%)  11 9/25 (36.00%)  9
Increased creatinine †  9/61 (14.75%)  9 6/33 (18.18%)  6 2/25 (8.00%)  2
Weight gain †  7/61 (11.48%)  7 4/33 (12.12%)  4 2/25 (8.00%)  2
Increase blood bilirubin †  3/61 (4.92%)  3 1/33 (3.03%)  1 1/25 (4.00%)  1
Increased lymphocyte count †  1/61 (1.64%)  1 0/33 (0.00%)  0 3/25 (12.00%)  3
Electrocardiogram QT corrected interval prolonged †  1/61 (1.64%)  1 0/33 (0.00%)  0 2/25 (8.00%)  2
Metabolism and nutrition disorders       
Hypoalbuminaemia †  42/61 (68.85%)  42 22/33 (66.67%)  22 9/25 (36.00%)  9
Anorexia †  32/61 (52.46%)  32 18/33 (54.55%)  18 7/25 (28.00%)  7
Hyponatremia †  25/61 (40.98%)  25 10/33 (30.30%)  10 13/25 (52.00%)  13
Hypomagnesemia †  24/61 (39.34%)  24 11/33 (33.33%)  11 6/25 (24.00%)  6
Hypokalemia †  19/61 (31.15%)  19 3/33 (9.09%)  3 10/25 (40.00%)  10
Hypocalcemia †  18/61 (29.51%)  18 7/33 (21.21%)  7 8/25 (32.00%)  8
Hypophosphatemia †  18/61 (29.51%)  18 4/33 (12.12%)  4 10/25 (40.00%)  10
Glucose intolerance †  17/61 (27.87%)  17 10/33 (30.30%)  10 5/25 (20.00%)  5
Dehydration †  6/61 (9.84%)  6 2/33 (6.06%)  2 6/25 (24.00%)  6
Hyperglycemia †  4/61 (6.56%)  4 4/33 (12.12%)  4 4/25 (16.00%)  4
Obesity †  3/61 (4.92%)  3 1/33 (3.03%)  1 2/25 (8.00%)  2
Hyperkalemia †  2/61 (3.28%)  2 3/33 (9.09%)  3 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain †  24/61 (39.34%)  24 13/33 (39.39%)  13 12/25 (48.00%)  12
Myalgia †  8/61 (13.11%)  8 6/33 (18.18%)  6 5/25 (20.00%)  5
Generalized muscle weakness †  8/61 (13.11%)  8 3/33 (9.09%)  3 1/25 (4.00%)  1
Arthritis †  7/61 (11.48%)  7 7/33 (21.21%)  7 0/25 (0.00%)  0
Neck pain †  7/61 (11.48%)  7 3/33 (9.09%)  3 3/25 (12.00%)  3
Arthralgia †  6/61 (9.84%)  6 5/33 (15.15%)  5 1/25 (4.00%)  1
Pain in extremity †  6/61 (9.84%)  6 5/33 (15.15%)  5 1/25 (4.00%)  1
Flank pain †  5/61 (8.20%)  5 4/33 (12.12%)  4 1/25 (4.00%)  1
Chest wall pain †  3/61 (4.92%)  3 1/33 (3.03%)  1 0/25 (0.00%)  0
Bone pain †  1/61 (1.64%)  1 0/33 (0.00%)  0 2/25 (8.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain †  3/61 (4.92%)  3 1/33 (3.03%)  1 0/25 (0.00%)  0
Nervous system disorders       
Peripheral sensory neuropathy †  26/61 (42.62%)  26 14/33 (42.42%)  14 5/25 (20.00%)  5
Headache †  19/61 (31.15%)  19 13/33 (39.39%)  13 11/25 (44.00%)  11
Dizziness †  15/61 (24.59%)  15 5/33 (15.15%)  5 6/25 (24.00%)  6
Dysgeusia †  12/61 (19.67%)  12 6/33 (18.18%)  6 1/25 (4.00%)  1
Peripheral motor neuropathy †  5/61 (8.20%)  5 3/33 (9.09%)  3 0/25 (0.00%)  0
Memory impairment †  3/61 (4.92%)  3 2/33 (6.06%)  2 2/25 (8.00%)  2
Tremor †  1/61 (1.64%)  1 2/33 (6.06%)  2 1/25 (4.00%)  1
Psychiatric disorders       
Insomnia †  27/61 (44.26%)  27 12/33 (36.36%)  12 10/25 (40.00%)  10
Anxiety †  17/61 (27.87%)  17 9/33 (27.27%)  9 10/25 (40.00%)  10
Depression †  9/61 (14.75%)  9 6/33 (18.18%)  6 7/25 (28.00%)  7
Renal and urinary disorders       
Urinary frequency †  12/61 (19.67%)  12 3/33 (9.09%)  3 3/25 (12.00%)  3
Urinary urgency †  6/61 (9.84%)  6 3/33 (9.09%)  3 1/25 (4.00%)  1
Urinary tract obstruction †  6/61 (9.84%)  6 1/33 (3.03%)  1 3/25 (12.00%)  3
Urinary incontinence †  5/61 (8.20%)  5 0/33 (0.00%)  0 1/25 (4.00%)  1
Urinary tract pain †  5/61 (8.20%)  5 2/33 (6.06%)  2 0/25 (0.00%)  0
Proteinuria †  3/61 (4.92%)  3 0/33 (0.00%)  0 0/25 (0.00%)  0
Reproductive system and breast disorders       
Vaginal discharge †  5/61 (8.20%)  5 3/33 (9.09%)  3 1/25 (4.00%)  1
Vaginal hemorrhage †  4/61 (6.56%)  4 1/33 (3.03%)  1 4/25 (16.00%)  4
Pelvic pain †  3/61 (4.92%)  3 5/33 (15.15%)  5 3/25 (12.00%)  3
Respiratory, thoracic and mediastinal disorders       
Dyspnea †  30/61 (49.18%)  30 20/33 (60.61%)  20 8/25 (32.00%)  8
Cough †  20/61 (32.79%)  20 12/33 (36.36%)  12 6/25 (24.00%)  6
Nasal congestion †  8/61 (13.11%)  8 2/33 (6.06%)  2 6/25 (24.00%)  6
Pleural effusion †  7/61 (11.48%)  7 4/33 (12.12%)  4 3/25 (12.00%)  3
Pneumonitis †  5/61 (8.20%)  5 0/33 (0.00%)  0 0/25 (0.00%)  0
Epistaxis †  4/61 (6.56%)  4 1/33 (3.03%)  1 4/25 (16.00%)  4
Hoarseness †  2/61 (3.28%)  2 4/33 (12.12%)  4 1/25 (4.00%)  1
Productive cough †  2/61 (3.28%)  2 3/33 (9.09%)  3 0/25 (0.00%)  0
Allergic rhinitis †  1/61 (1.64%)  1 3/33 (9.09%)  3 3/25 (12.00%)  3
Sore throat †  2/61 (3.28%)  2 3/33 (9.09%)  3 2/25 (8.00%)  2
Skin and subcutaneous tissue disorders       
Maculopapular rash †  24/61 (39.34%)  24 3/33 (9.09%)  3 11/25 (44.00%)  11
Alopecia †  22/61 (36.07%)  22 7/33 (21.21%)  7 6/25 (24.00%)  6
Pruritis †  20/61 (32.79%)  20 5/33 (15.15%)  5 2/25 (8.00%)  2
Acneiform rash †  8/61 (13.11%)  8 1/33 (3.03%)  1 0/25 (0.00%)  0
Dry skin †  7/61 (11.48%)  7 3/33 (9.09%)  3 2/25 (8.00%)  2
Nail discoloration †  1/61 (1.64%)  1 2/33 (6.06%)  2 0/25 (0.00%)  0
Pain of skin †  0/61 (0.00%)  0 2/33 (6.06%)  2 0/25 (0.00%)  0
Night sweats †  2/61 (3.28%)  2 0/33 (0.00%)  0 3/25 (12.00%)  3
Vascular disorders       
Hypertension †  36/61 (59.02%)  36 14/33 (42.42%)  14 8/25 (32.00%)  8
Thromboembolic event †  10/61 (16.39%)  10 7/33 (21.21%)  7 5/25 (20.00%)  5
Flushing †  6/61 (9.84%)  6 3/33 (9.09%)  3 2/25 (8.00%)  2
Hot flashes †  3/61 (4.92%)  3 5/33 (15.15%)  5 2/25 (8.00%)  2
Hypotension †  3/61 (4.92%)  3 0/33 (0.00%)  0 1/25 (4.00%)  1
Phlebitis †  3/61 (4.92%)  3 2/33 (6.06%)  2 0/25 (0.00%)  0
Lymphedema †  0/61 (0.00%)  0 2/33 (6.06%)  2 1/25 (4.00%)  1
Hematoma †  1/61 (1.64%)  1 2/33 (6.06%)  2 0/25 (0.00%)  0
†
Indicates events were collected by systematic assessment
  • Randomization in a 2:1 ratio is associated with reduced statistical power - increased the sample size by 12% compared to a 1:1 randomization design
  • No stratification factors because of the small sample size, potentially resulting in imbalances in BRCA mutation status
  • Absence of quality-of-life assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Amit Oza
Organization: University Health Network - Princess Margaret Cancer Centre
Phone: 416-946-4501 ext 3911
EMail: Amit.Oza@uhn.ca
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: NCT02101775    
Obsolete Identifiers: NCT02151292
Other Study ID Numbers: NCI-2014-00620
NCI-2014-00620 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHL-093
NCI 9568
9568 ( Other Identifier: University Health Network-Princess Margaret Hospital )
9568 ( Other Identifier: CTEP )
N01CM00032 ( U.S. NIH Grant/Contract )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
UM1CA186644 ( U.S. NIH Grant/Contract )
UM1CA186705 ( U.S. NIH Grant/Contract )
First Submitted: March 28, 2014
First Posted: April 2, 2014
Results First Submitted: March 21, 2023
Results First Posted: September 8, 2023
Last Update Posted: March 8, 2024