Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04884360 | D9319C00001- 1L OC Mono Global RCT | PHASE3 | ACTIVE NOT_RECRUITING | 366 | — | — | May 31, 2021 | Jul 27, 2027 | Mar 2, 2026 | 89 | Chile, China +8 |
| NCT04421963 | Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | PHASE3 | ACTIVE NOT_RECRUITING | 185 | — | — | Aug 4, 2020 | Apr 6, 2027 | Apr 16, 2026 | 107 | United States, Belgium +21 |
| NCT01081951 | 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 | PHASE2 | ACTIVE NOT_RECRUITING | 162 | — | — | Feb 4, 2010 | Dec 31, 2026 | May 13, 2026 | 53 | United States, Australia +11 |
| NCT02121990 | Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer | PHASE1 | COMPLETED | 17 | — | — | Apr 21, 2014 | Aug 19, 2020 | Aug 21, 2020 | 5 | United States |
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
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).
This is a dose-finding Phase 1 study, which employs a 3+3 design, and aims to identify the MTD of a combination of traditional and novel agents for front-line therapy of optimally debulked ovarian cancer.
| Arm | Type | Description |
|---|---|---|
| Group A: Olaparib tablets 300 mg oral twice daily (n=238). | EXPERIMENTAL | Participants in Group A will receive olaparib tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator's opinion they are benefiting from treatment and do not meet any other discontinuation criteria. |
| Group B: Placebo tablets 300 mg oral twice daily (n=118) | PLACEBO_COMPARATOR | Participants in Group B will receive matching placebo tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator's opinion they are benefiting from treatment and do not meet any other discontinuation criteria. |
| Olaparib | EXPERIMENTAL | Treatment |
| 1 | EXPERIMENTAL | Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. |
| 2 | ACTIVE_COMPARATOR | paclitaxel iv and carboplatin iv |
| Cisplatin, Paclitaxel, bevacizumab & olaparib | EXPERIMENTAL | All treatments will be given in the outpatient setting. A cycle is 21 days. The sequence of infusions on Day 1 will be IV paclitaxel (135 mg/m2), then IV bevacizumab (15 mg/kg, beginning Cycle 2). On Day 2 patients will receive IP cisplatin (75 mg/m2). Patients will be given twice-daily treatment with oral olaparib in cycles 1-6 for 7 consecutive days, starting on Day 2 (Days 2-8). IP paclitaxel (60 mg/m2) will be given on Day 8. Sequential cohorts of 3 patients will receive escalating doses of olaparib (50mg BID, 100mg BID, 200mg BID). |
| Name | Type | Description |
|---|---|---|
| Olaparib | DRUG | Olaparib tablets 300 mg oral twice daily |
| Matching placebo | OTHER | Matching placebo tablets taken orally at a dose of 300 mg twice daily |
| paclitaxel | DRUG | 175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle |
| carboplatin | DRUG | AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle |
| Drug: carboplatin | DRUG | AUC4 iv for up to 6 cycles (18 weeks) |
| Paclitaxel, | DRUG | - |
| Bevacizumab | DRUG | - |
| Cisplatin | DRUG | - |
Key Inclusion Criteria: 1. Participants must be ≥18 years at the time of (pre-)screening 2. Histological and staging criteria:Female participants who must have histologically newly diagnosed high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal ca...