NCT05636111 Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer
| NCT ID | NCT05636111 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-07-12 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.
Eligibility Criteria
Inclusion Criteria: Inclusion criteria will be assessed within 28 days of starting study treatment: 1. Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines. 2. Age ≥ 18 years at time of study entry 3. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 4. Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory\* or platinum resistant\*\* disease are allowed. Prior anti-VEGF targeted therapy (e.g. bevacizumab, VEGF TKI's) is allowed. * Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose. * Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy 5. Prior Therapy: Unlimited prior systemic therapies are allowed. 6. ECOG performance status of 0-1 (Appendix A)
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