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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05494580 | Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer | PHASE1 | COMPLETED | 29 | — | — | Sep 22, 2022 | Jan 31, 2026 | Mar 10, 2026 | 1 | China |
Determine the RP2D of the pamiparib and surufatinib combination
The percentage of patients alive without documented progression 6 months after treatment initiation.
| Arm | Type | Description |
|---|---|---|
| Pamiparib + Surufatinib (Phase Ib/II) | EXPERIMENTAL | Phase Ib: A dose de-escalation schedule is used in the phase Ib dose finding part. Dose Level 1 (starting dose): pamiparib 40 mg administered orally twice daily (fixed dose) and surufatinib 250 mg administered orally once daily on a 21-day treatment cycle. If ≥2/6 patients experience a dose limiting toxicity (DLT), we will de-escalate to Dose Level 2: pamiparib 40 mg administered orally twice daily (fixed dose) and surufatinib 200 mg administered orally once daily on a 21-day treatment cycle. Approximately 3-12 patients will be enrolled in phase Ib study. Phase II: The phase II part will begin once the recommended phase 2 dose (RP2D) of surufatinib have been determined in the Phase Ib in order to assess antitumor activity of pamiparib and surufatinib combination. In phase II study, pamiparib 40 mg orally twice daily and surufatinib PR2D will be administered. |
| Name | Type | Description |
|---|---|---|
| Pamiparib | DRUG | Oral |
| Surufatinib | DRUG | Oral |
Inclusion Criteria: 1. Signed Informed Consent Form; 2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 3. Platinum-resistant disease, defined as progression within 6 months from completion of most recent platinum-containing therapy. Subject ...