Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer (NCT NCT01081951)

NCT ID: NCT01081951

Last Updated: 2026-02-05

Results Overview

PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

162 participants

Primary outcome timeframe

Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

Results posted on

2026-02-05

Participant Flow

The first patient was enrolled on 12-Feb-2010. The last patient was enrolled on 15-Jul-2010. Patients were enrolled at 43 sites in 12 countries: Australia, Belgium, Canada, Czech Republic, Germany, Italy, Japan, the Netherlands, Panama, Spain, the UK and the USA. 173 patients were screened and 162 patients were enrolled to receive treatment.

Patient randomisation was stratified(using an interactive voice response \[IVR\]system) based on:1) number of prior platinum-containing treatment lines received(1or\>1) and 2)time to disease progression following completion of the previous platinum-containing therapy(\>6to\<=12 months or\>12 months).Six patients in the C6/P arm did not receive treatment.

Participant milestones

Participant milestones
Measure	Olaparib/Carboplatin AUC4/Paclitaxel Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered
Overall Study STARTED	81	81
Overall Study Received Study Treatment	81	75
Overall Study Entered Maintenance Phase	66	55
Overall Study Ongoing Study Treatment at Data Cut-off	11	0
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	56	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Olaparib/Carboplatin AUC4/Paclitaxel Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered
Overall Study Death	54	47
Overall Study Withdrawal by Subject	2	6
Overall Study Allocated treatment but did not take it	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib/Carboplatin AUC4/Paclitaxel n=81 Participants Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel n=81 Participants Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered	Total n=162 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 10.0 • n=25 Participants	59.0 years STANDARD_DEVIATION 10.7 • n=26 Participants	58.5 years STANDARD_DEVIATION 10.3 • n=51 Participants
Age, Customized < 50	15 Participants n=25 Participants	17 Participants n=26 Participants	32 Participants n=51 Participants
Age, Customized ≥ 50 - < 65	45 Participants n=25 Participants	40 Participants n=26 Participants	85 Participants n=51 Participants
Age, Customized ≥ 65	21 Participants n=25 Participants	24 Participants n=26 Participants	45 Participants n=51 Participants
Sex: Female, Male Female	81 Participants n=25 Participants	81 Participants n=26 Participants	162 Participants n=51 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Number of prior platinum-containing treatment lines 1	58 Participants n=25 Participants	53 Participants n=26 Participants	111 Participants n=51 Participants
Number of prior platinum-containing treatment lines >1	23 Participants n=25 Participants	28 Participants n=26 Participants	51 Participants n=51 Participants
Time to disease progression on completion of the previous platinum therapy PD > 6 to ≤ 12 months after completion	39 Participants n=25 Participants	40 Participants n=26 Participants	79 Participants n=51 Participants
Time to disease progression on completion of the previous platinum therapy PD >12 months after completion	42 Participants n=25 Participants	41 Participants n=26 Participants	83 Participants n=51 Participants
Classification of BRCA status BRCAm	20 Participants n=25 Participants	21 Participants n=26 Participants	41 Participants n=51 Participants
Classification of BRCA status BRCAwt	30 Participants n=25 Participants	29 Participants n=26 Participants	59 Participants n=51 Participants
Classification of BRCA status BRCA VUS	4 Participants n=25 Participants	3 Participants n=26 Participants	7 Participants n=51 Participants
Classification of BRCA status BRCA missing	27 Participants n=25 Participants	28 Participants n=26 Participants	55 Participants n=51 Participants

PRIMARY outcome

Timeframe: Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

Population: Full Analysis Set (FAS)

Outcome measures

Outcome measures
Measure	Olaparib/Carboplatin AUC4/Paclitaxel n=81 Participants Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel n=81 Participants Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered
Progression Free Survival (PFS)	12.2 months Interval 9.7 to 15.0	9.6 months Interval 9.1 to 9.7

SECONDARY outcome

Timeframe: Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)

Population: FAS

OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. Updated OS based on final OS analysis (DCO 31 January 2014)

Outcome measures

Outcome measures
Measure	Olaparib/Carboplatin AUC4/Paclitaxel n=81 Participants Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel n=81 Participants Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered
Overall Survival (OS)	54 Participants (Number of deaths)	47 Participants (Number of deaths)

SECONDARY outcome

Timeframe: Week 9 (+/- 1 week)

Population: FAS, but including only patients with target lesions at baseline

The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as \[(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions\]\*100 for each patient. Imputations were used for missing data where possible.

Outcome measures

Outcome measures
Measure	Olaparib/Carboplatin AUC4/Paclitaxel n=70 Participants Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel n=67 Participants Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered
Percentage Change in Tumour Size	-38.4 Percentage change Standard Error 4.0	-39.1 Percentage change Standard Error 4.0

Adverse Events

Olaparib/Carboplatin AUC4/Paclitaxel

Serious events: 17 serious events

Other events: 81 other events

Deaths: 54 deaths

Carboplatin AUC6/Paclitaxel

Serious events: 19 serious events

Other events: 72 other events

Deaths: 47 deaths

Serious adverse events

Other adverse events

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Olaparib/Carboplatin AUC4/Paclitaxel n=81 participants at risk Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)	Carboplatin AUC6/Paclitaxel n=75 participants at risk Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered
Blood and lymphatic system disorders Anaemia	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	2.7% 2/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Blood and lymphatic system disorders Febrile Neutropenia	3.7% 3/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Blood and lymphatic system disorders Neutropenia	3.7% 3/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Cardiac disorders Angina Unstable	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Eye disorders Entropion	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Eye disorders Eyelid Ptosis	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Gastrointestinal disorders Abdominal Pain	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	2.7% 2/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Gastrointestinal disorders Abdominal Pain Upper	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Gastrointestinal disorders Gastrointestinal Obstruction	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Gastrointestinal disorders Gastrointestinal Pain	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Gastrointestinal disorders Small Intestinal Obstruction	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Gastrointestinal disorders Vomiting	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
General disorders Pyrexia	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Hepatobiliary disorders Hepatitis Acute	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Immune system disorders Anaphylactic Reaction	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Immune system disorders Anaphylactic Shock	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Immune system disorders Drug Hypersensitivity	2.5% 2/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	2.7% 2/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Infections and infestations Cytomegalovirus Infection	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Infections and infestations Enterocolitis Infectious	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Infections and infestations Muscle Abscess	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Infections and infestations Urinary Tract Infection	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Injury, poisoning and procedural complications Femoral Neck Fracture	2.5% 2/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Investigations Coagulation Time Prolonged	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Nervous system disorders Polyneuropathy	0.00% 0/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	1.3% 1/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.2% 1/81 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).	0.00% 0/75 Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).