BENITIONSClinical Trial Intelligence

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

ConditionMetastatic Fallopian Tube Carcinoma, Metastatic Ovarian Carcinoma, Metastatic Primary Peritoneal Carcinoma, Ovarian Endometrioid Tumor
PhasePhase 1
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment35 participants
InterventionsBerzosertib, Carboplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
Start dateMay 16, 2017
Completion dateOct 4, 2024
Results postedApr 2, 2026

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 11 Participants
Dose Level 22 Participants

Incidence of Adverse Events

Up to 3 years · Participants

Dose Level 128 Participants
Dose Level 25 Participants
Dose Level 118 Participants
Dose Level 24 Participants
Dose Level 10 Participants
Dose Level 20 Participants

Open in BENITIONS View on ClinicalTrials.gov

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