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
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| ClinicalTrials.gov Identifier: NCT01081951 |
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Recruitment Status :
Active, not recruiting
First Posted : March 5, 2010
Results First Posted : December 10, 2012
Last Update Posted : January 7, 2021
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Ovarian Cancer |
| Interventions |
Drug: olaparib Drug: paclitaxel Drug: carboplatin Drug: Drug: carboplatin |
| Enrollment | 162 |
Participant Flow
| Recruitment Details | 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. |
| Pre-assignment Details | 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. |
| Arm/Group Title | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
 Arm/Group Description |
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) |
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 |
| Period Title: Overall Study | ||
| Started | 81 | 81 |
| Received Study Treatment | 81 | 75 |
| Entered Maintenance Phase | 66 | 55 |
| Ongoing Study Treatment at Data Cut-off | 11 | 0 |
| Completed | 25 [1] | 26 [2] |
| Not Completed | 56 | 55 |
| Reason Not Completed | ||
| Death | 54 | 47 |
| Withdrawal by Subject | 2 | 6 |
| Allocated treatment but did not take it | 0 | 1 |
| Lost to Follow-up | 0 | 1 |
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[1]
Completed is ongoing study at DCO (Data cut-off),either on-treatment or in survival follow-up
[2]
Completed is ongoing study at DCO (Data cut-off), either on-treatment or in survival follow-up
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Baseline Characteristics
| Arm/Group Title | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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) |
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 of all reporting groups | |
| Overall Number of Baseline Participants | 81 | 81 | 162 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 81 participants | 81 participants | 162 participants | |
| 57.9 (10.0) | 59.0 (10.7) | 58.5 (10.3) | ||
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 81 participants | 81 participants | 162 participants |
| < 50 | 15 | 17 | 32 | |
| ≥ 50 - < 65 | 45 | 40 | 85 | |
| ≥ 65 | 21 | 24 | 45 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 81 participants | 81 participants | 162 participants | |
| Female |
81 100.0%
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81 100.0%
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162 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Number of prior platinum-containing treatment lines
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 81 participants | 81 participants | 162 participants |
| 1 | 58 | 53 | 111 | |
| >1 | 23 | 28 | 51 | |
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Time to disease progression on completion of the previous platinum therapy
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 81 participants | 81 participants | 162 participants |
| PD > 6 to ≤ 12 months after completion | 39 | 40 | 79 | |
| PD >12 months after completion | 42 | 41 | 83 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Gerard Lynch |
| Organization: | AstraZeneca |
| EMail: | aztrial_results_posting@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01081951 |
| Other Study ID Numbers: |
D0810C00041 |
| First Submitted: | February 26, 2010 |
| First Posted: | March 5, 2010 |
| Results First Submitted: | November 12, 2012 |
| Results First Posted: | December 10, 2012 |
| Last Update Posted: | January 7, 2021 |