Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Phase 1
Active, not recruiting
NCT02627443
| Condition | Metastatic Fallopian Tube Carcinoma, Metastatic Ovarian Carcinoma, Metastatic Primary Peritoneal Carcinoma, Ovarian Endometrioid Tumor |
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| Phase | Phase 1 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 35 participants |
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| Interventions | Berzosertib, Carboplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study |
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| Start date | May 16, 2017 |
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| Completion date | Oct 4, 2024 |
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| Results posted | Apr 2, 2026 |
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Summary
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and berzosertib when given together with carboplatin in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Chemotherapy drugs, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving berzosertib with chemotherapy (carboplatin and gemcitabine hydrochloride) may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer compared to chemotherapy alone.
Dost Limiting Toxicity (DLT) (Phase I Dose Escalation)
Up to 28 days · Participants
| Dose Level 1 | 1 Participants |
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| Dose Level 2 | 2 Participants |
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Incidence of Adverse Events
Up to 3 years · Participants
| Dose Level 1 | 28 Participants |
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| Dose Level 2 | 5 Participants |
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| Dose Level 1 | 18 Participants |
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| Dose Level 2 | 4 Participants |
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| Dose Level 1 | 0 Participants |
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| Dose Level 2 | 0 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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