Trial Outcomes & Findings for Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer (NCT NCT02893917)
NCT ID: NCT02893917
Last Updated: 2026-04-13
Results Overview
The two study arms will be compared for radiographic progression free survival with Kaplan-Meier estimates and log-rank tests. The Rothman confidence interval, which is based on Greenwood's variance, Thomas and Grunkemeier confidence interval, and the simultaneous confidence bands by Nair and Hall and Wellner, will be reported. In addition, the possible confounding variables will be compared for survival with log-rank test.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed up to 5 years
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Arm A (Olaparib, Cediranib)
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
Received Intervention
|
44
|
45
|
|
Overall Study
Discontinued Treatment
|
44
|
45
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Olaparib, Cediranib)
n=45 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=193 Participants
|
70 years
n=193 Participants
|
69 years
n=386 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=193 Participants
|
45 Participants
n=193 Participants
|
90 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
37 Participants
n=193 Participants
|
38 Participants
n=193 Participants
|
75 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
8 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
15 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=193 Participants
|
45 participants
n=193 Participants
|
90 participants
n=386 Participants
|
|
ECOG Performance Status Scale
|
22 Participants
n=193 Participants
|
23 Participants
n=193 Participants
|
45 Participants
n=386 Participants
|
|
Prostate-Specific Antigen (PSA)
|
86.9 ng/mL
n=193 Participants
|
58.4 ng/mL
n=193 Participants
|
72.5 ng/mL
n=386 Participants
|
|
Measurable disease (yes/no)
Yes
|
31 Participants
n=193 Participants
|
33 Participants
n=193 Participants
|
64 Participants
n=386 Participants
|
|
Measurable disease (yes/no)
No
|
14 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
26 Participants
n=386 Participants
|
|
Liver Metastases (Yes/No)
Yes
|
10 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
|
Liver Metastases (Yes/No)
No
|
35 Participants
n=193 Participants
|
35 Participants
n=193 Participants
|
70 Participants
n=386 Participants
|
|
Any Novel Hormonal Agent (Yes/No)
Yes
|
45 Participants
n=193 Participants
|
43 Participants
n=193 Participants
|
88 Participants
n=386 Participants
|
|
Any Novel Hormonal Agent (Yes/No)
No
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Prior Cytotoxic Chemotherapy
1 cytotoxic chemotherapy
|
17 Participants
n=193 Participants
|
20 Participants
n=193 Participants
|
37 Participants
n=386 Participants
|
|
Prior Cytotoxic Chemotherapy
2 or more cytotoxic chemotherapies
|
20 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
32 Participants
n=386 Participants
|
|
Prior Cytotoxic Chemotherapy
no prior cytotoxic chemotherapy
|
8 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
21 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed up to 5 yearsThe two study arms will be compared for radiographic progression free survival with Kaplan-Meier estimates and log-rank tests. The Rothman confidence interval, which is based on Greenwood's variance, Thomas and Grunkemeier confidence interval, and the simultaneous confidence bands by Nair and Hall and Wellner, will be reported. In addition, the possible confounding variables will be compared for survival with log-rank test.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=45 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Radiographic Progression Free Survival
|
8.5 months
Interval 5.4 to 12.0
|
4.0 months
Interval 3.2 to 8.5
|
SECONDARY outcome
Timeframe: Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 5 yearsPopulation: Intention to treat
Will use the rank preserving structure failure time model for the overall survival analysis.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=45 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Overall Survival
|
11.8 months
Interval 10.33 to
Insufficient number of participants with events.
|
17.3 months
Interval 15.5 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 64 patients were evaluable for objective response by RECIST v1.1 criteria.
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. The exact 95% confidence interval of objective response rate will be reported based on the binomial distribution. The multivariate data analysis will be completed using the logistic regression model. The adjusted p-value and adjusted 95% confidence interval will also be reported.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=33 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=31 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Objective Response Rate
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Intention to treat
Prostate-specific antigen response will be defined by prostate-specific antigen decline from baseline \> 50%, confirmed by a second value at 3-4 weeks later. Prostate-specific antigen response rate analysis will be based on a subset of patients who had prostate-specific antigen progression prior to enrollment. The multivariate data analysis will be completed using the logistic regression model.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=45 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Prostate-specific Antigen Response Rate
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 1 week prior to start of therapyPopulation: Data are for those with evaluable data and then split by HRD status.
Homologous recombination deficiency positive status is defined by presence of homozygous deletion or deleterious mutations in key homologous recombination genes of deoxyribonucleic acid repair genes as analyzed by BROCA-homologous recombination test. The data analysis will be completed using log rank Test. The multivariate data analysis will be completed using the Cox PH model.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=41 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=43 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Correlation Between Homologous Recombination Deficiency Status and Radiographic Progression Free Survival
HRD positive
|
10.63 months
Interval 5.9 to
Insufficient number of participants with events.
|
3.83 months
Interval 2.33 to
Insufficient number of participants with events.
|
|
Correlation Between Homologous Recombination Deficiency Status and Radiographic Progression Free Survival
HRD negative
|
5.47 months
Interval 3.73 to 11.77
|
4.03 months
Interval 3.73 to 8.47
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be assessed by whole exome sequencing and transcriptome sequencing. The biomarker data analysis will be completed using Lasso-based elastic net method.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=45 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Incidence of Genomic Alterations
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 will be effective by April 1, 2018). Descriptive statistics, including means, standard deviations, and ranges for continuous parameters, as well as percentages and frequencies for categorical parameters, will be presented. Adverse medical events will be tabulated. NCI toxicity grade 3 and grade 4 laboratory abnormalities will be listed and tabled. At the time of results reporting, presented are the count of participants in either arm that experienced at least 1 adverse event.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib)
n=44 Participants
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Incidence of Adverse Events
|
44 Participants
|
45 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe data analysis will be completed using Lasso-based elastic net method.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe data analysis will be completed using Lasso-based elastic net method.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Olaparib, Cediranib)
Serious events: 21 serious events
Other events: 44 other events
Deaths: 35 deaths
Arm B (Olaparib)
Serious events: 21 serious events
Other events: 45 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Arm A (Olaparib, Cediranib)
n=44 participants at risk
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 participants at risk
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
2/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
6.8%
3/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
6.8%
3/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
9.1%
4/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Investigations
Creatinine increased
|
0.00%
0/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
General disorders
Death NOS
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
2/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Nervous system disorders
Depressed level of consciousness
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
2/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.6%
6/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/44 • Up to 5 years
|
6.7%
3/45 • Up to 5 years
|
|
General disorders
Fatigue
|
4.5%
2/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
General disorders
Fever
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.5%
2/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.3%
1/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Reproductive system and breast disorders
Genital edema
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Vascular disorders
Hematoma
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
General disorders
Pain
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Gastrointestinal disorders
Proctitis
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.3%
1/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44 • Up to 5 years
|
2.2%
1/45 • Up to 5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/44 • Up to 5 years
|
4.4%
2/45 • Up to 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
2.3%
1/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
Other adverse events
| Measure |
Arm A (Olaparib, Cediranib)
n=44 participants at risk
Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Olaparib: Given PO
|
Arm B (Olaparib)
n=45 participants at risk
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Olaparib: Given PO
|
|---|---|---|
|
Nervous system disorders
Fatigue
|
65.9%
29/44 • Up to 5 years
|
51.1%
23/45 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
63.6%
28/44 • Up to 5 years
|
26.7%
12/45 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
47.7%
21/44 • Up to 5 years
|
20.0%
9/45 • Up to 5 years
|
|
Endocrine disorders
Hypertension
|
45.5%
20/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
43.2%
19/44 • Up to 5 years
|
42.2%
19/45 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
31.8%
14/44 • Up to 5 years
|
42.2%
19/45 • Up to 5 years
|
|
Metabolism and nutrition disorders
Weight Loss
|
25.0%
11/44 • Up to 5 years
|
6.7%
3/45 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
9/44 • Up to 5 years
|
15.6%
7/45 • Up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
20.5%
9/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
|
Investigations
Plt count decreased
|
18.2%
8/44 • Up to 5 years
|
15.6%
7/45 • Up to 5 years
|
|
Investigations
WBC decreased
|
15.9%
7/44 • Up to 5 years
|
13.3%
6/45 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
15.9%
7/44 • Up to 5 years
|
11.1%
5/45 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.6%
6/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
Immune system disorders
Headache
|
13.6%
6/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
Investigations
Lymphocyte decreased
|
13.6%
6/44 • Up to 5 years
|
15.6%
7/45 • Up to 5 years
|
|
Investigations
Creatinine Increased
|
9.1%
4/44 • Up to 5 years
|
11.1%
5/45 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
4.5%
2/44 • Up to 5 years
|
8.9%
4/45 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
4.5%
2/44 • Up to 5 years
|
0.00%
0/45 • Up to 5 years
|
Additional Information
Joseph Kim, MD
Yale School of Medicine: Medical Oncology
Phone: (203) 200-4822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60