Trial Outcomes & Findings for Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer (NCT NCT02345265)

Last Updated: 2025-09-16

Results Overview

PFS determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Homologous recombination repair (HRR) status was measured by the BROCA-HR assay. BROCA-HR is a targeted NGS platform including all known gynecologic cancer susceptibility genes and other DNA repair or related genes as well as a 3100 single nucleotide polymorphism panel to increase coverage for loss of heterozygosity (LOH) analysis. HRR status was associated as a pooled group against PFS using the Kaplan-Meier product-limit estimator with 95% confidence bands derived using Greenwood's formula.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first, assessed up to 32 months.

Results posted on

2025-09-16

Participant Flow

Participants were recruited at 12 academic medical centers. The first participant was enrolled on May 23, 2016 and the last patient was enrolled on June 28, 2017.

A total of 70 participants enrolled to the study and received study intervention.

Participant milestones

Participant milestones
Measure	Cediranib/Olaparib in Platinum-Resistant Ovarian Cancer Participants with platinum-resistant ovarian cancer received olaparib 200 mg orally twice daily and cediranib 30 mg orally once daily. Platinum-resistance is defined as disease progression within 6 months of platinum-based chemotherapy.	Cediranib/Olaparib in Platinum-Sensitive Ovarian Cancer Participants with platinum-sensitive ovarian cancer received olaparib 200 mg orally twice daily and cediranib 30 mg orally once daily. Platinum-sensitive disease is defined as cancer that has not progressed within 6 months of the last receipt of platinum-based chemotherapy.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cediranib/Olaparib in Platinum-Resistant Ovarian Cancer n=35 Participants Participants with platinum-resistant ovarian cancer received olaparib 200 mg orally twice daily and cediranib 30 mg orally once daily. Platinum-resistance is defined as disease progression within 6 months of platinum-based chemotherapy.	Cediranib/Olaparib in Platinum-Sensitive Ovarian Cancer n=35 Participants Participants with platinum-sensitive ovarian cancer received olaparib 200 mg orally twice daily and cediranib 30 mg orally once daily. Platinum-sensitive disease is defined as cancer that has not progressed within 6 months of the last receipt of platinum-based chemotherapy.	Total n=70 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
BRCA Status Wild Type	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
BRCA Status Mutation	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
BRCA Status Unknown	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
ECOG Performance Status 0	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
ECOG Performance Status 1	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
ECOG Performance Status 2	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Primary Site of Disease Ovary	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Primary Site of Disease Fallopian Tube	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Number of Prior Lines 1	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Number of Prior Lines 2	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Number of Prior Lines 3	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Number of Prior Lines 4	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Platinum Status Platinum Resistant	35 Participants n=5 Participants	0 Participants n=7 Participants	35 Participants n=5 Participants
Platinum Status Platinum Sensitivity 6-12 Months	0 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants
Platinum Status Platinum Sensitivity >12 Months	0 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first, assessed up to 32 months.

Population: Results are not reported for patients in the platinum-resistant ovarian cancer cohort as this primary objective pertained only to platinum-sensitive ovarian cancer.

Outcome measures

Outcome measures
Measure	HRRmt n=22 Participants Genes included as homologous recombination repair mutant type (HRRmt): ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12 (somatic), NBN, PALB2, RAD51C, RAD51D	HRRwt n=13 Participants homologous recombination repair wild type (HRRwt)
Progression-Free Survival (PFS) by HRR Status in Platinum-Sensitive Ovarian Cancer	16.79 months Interval 11.27 to 18.56	16.43 months Interval 9.4 to Not enough events to estimate upper confidence limit

PRIMARY outcome

Timeframe: Up to 32 months

Population: Results are not reported for patients in the platinum-sensitive ovarian cancer cohort as this primary objective pertained only to platinum-resistant ovarian cancer.

Responses determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where Objective Response (OR) represents either a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); Objective Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	HRRmt n=35 Participants Genes included as homologous recombination repair mutant type (HRRmt): ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12 (somatic), NBN, PALB2, RAD51C, RAD51D	HRRwt homologous recombination repair wild type (HRRwt)
Objective Response Rate (ORR) in Platinum-Resistant Ovarian Cancer	22.86 percentage of participants Interval 10.42 to 40.14	—

SECONDARY outcome

Timeframe: Up to 30 days post-treatment

Will summarize the distribution of all candidate markers using descriptive statistics and non-parametric tests of their association with patient and disease characteristics. Biomarker profiles will be explored using unsupervised hierarchical clustering of all analytes and patients. The association of each candidate marker to progression-free survival will be evaluated by Cox proportional hazard models using a two-sided alpha = 0.05, while estimating the false discovery rate for any sets of identified markers by the Benjamini-Hochberg step-up procedure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Will be summarized using the Kaplan-Meier product-limit estimator with 95% confidence bands derived using Greenwood's formula.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Will be detected by the BROCA-homologous recombination assay. Descriptive statistics will be used to summarize the genetic alterations detected by the BROCA-homologous recombination assay and Bioinformatics Pipeline. The prevalence of each genetic alteration will be reported overall, and within stratum defined by platinum-sensitive and platinum-resistant disease using binomial exact 95% confidence intervals. The primary analysis will associate BRCA mutations (germline or somatic) and other homologous recombination gene mutation (as a pooled group) with/against progression-free survival as a time-to-event endpoint, using Kaplan-Meier product-limit estimates and stratified logrank test using a two-sided alpha of 0.05.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to day 3

Will determine if there is an association between levels of circulating endothelial cells at baseline, or the change in circulating endothelial cells from baseline to day 3, and progression-free survival in patients receiving cediranib maleate/olaparib trial, and to determine if there are significant changes from baseline to day 3 in the levels of circulating endothelial cells. Will use a paired t-test. In addition, if the paired differences in values are not normally distributed (p \< 0.05 by a Shapiro-Wilk test), then a Wilcoxon signed rank test will be used instead of a paired t-test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

The prevalence of each genetic alteration will be reported overall, and within platinum-sensitive and platinum-resistant cohorts using binomial exact 95% confidence intervals. Exploratory analyses will associate alterations of a single-gene against progression-free survival as a time-to-event endpoint, using Kaplan-Meier product-limit estimates and logrank test using a nominal two-sided alpha of 0.05.

Outcome measures

Outcome data not reported

Adverse Events

Cediranib/Olaparib in Platinum-Sensitive Ovarian Cancer

Serious events: 15 serious events

Other events: 35 other events

Deaths: 9 deaths

Cediranib/Olaparib in Platinum-Resistant Ovarian Cancer

Serious events: 15 serious events

Other events: 35 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Joyce Liu

Dana-Farber Cancer Institute

Phone: 617-632-5269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Cediranib/Olaparib in Platinum-Sensitive Ovarian Cancer n=35 participants at risk Cediranib/Olaparib in Platinum-Sensitive Ovarian Cancer Participants with platinum-sensitive ovarian cancer received olaparib 200 mg orally twice daily and cediranib 30 mg orally once daily. Platinum-sensitive disease is defined as cancer that has not progressed within 6 months of the last receipt of platinum-based chemotherapy.	Cediranib/Olaparib in Platinum-Resistant Ovarian Cancer n=35 participants at risk Participants with platinum-resistant ovarian cancer received olaparib 200 mg orally twice daily and cediranib 30 mg orally once daily. Platinum-resistance is defined as disease progression within 6 months of platinum-based chemotherapy.
Cardiac disorders Chest pain - cardiac	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Cardiac disorders Sinus bradycardia	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	14.3% 5/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Colitis	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	8.6% 3/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Colonic obstruction	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Constipation	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	8.6% 3/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Diarrhea	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders GI Bleed	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Nausea	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders small intestinal obstruction	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	22.9% 8/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Gastrointestinal disorders Vomiting	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
General disorders Fatigue	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Immune system disorders SIRS	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Infections and infestations Lung infection	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Infections and infestations Sepsis	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Investigations Blood bilirubin increased	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Metabolism and nutrition disorders Dehydration	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Metabolism and nutrition disorders Hypocalcemia	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Metabolism and nutrition disorders Hypokalemia	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Nervous system disorders Amnesia	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Nervous system disorders Cognitive disturbance	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Nervous system disorders Concentration impairment	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Nervous system disorders Seizure	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Psychiatric disorders Anxiety	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	5.7% 2/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).
Vascular disorders Thromboembolic event	2.9% 1/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).	0.00% 0/35 • Adverse event data was collected throughout duration of therapy (up to 32 months).