BENITIONSClinical Trial Intelligence

Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

1상 진행 중(모집 완료) NCT02627443

대상 질환Metastatic Fallopian Tube Carcinoma, Metastatic Ovarian Carcinoma, Metastatic Primary Peritoneal Carcinoma, Ovarian Endometrioid Tumor
임상 단계1상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수35 명
중재(약물)Berzosertib, Carboplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
시작일2017년 5월 16일
완료일2024년 10월 4일
결과 공개일2026년 4월 2일

요약

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

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