CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Berzosertib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02567409
NCT02567409Phase 2Completed

A Randomized Phase 2 Trial of Cisplatin/Gemcitabine With or Without M6620 (VX-970) in Metastatic Urothelial Carcinoma

National Cancer Institute (NCI)·interventional·Posted Oct 5, 2015·Updated Mar 3, 2025

In Brief

A Phase 2 clinical trial evaluating Berzosertib, Cisplatin, and 1 other intervention for Metastatic Bladder Urothelial Carcinoma and 3 related conditions. Completed, enrolled 87 participants across 39 sites.

Detailed Summary

This phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without berzosertib works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin 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. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with berzosertib in treating patients with urothelial cancer.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 5, 2015
Enrollment StartJan 31, 2017
Primary CompletionApr 21, 2023
Study CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 10.7 years ago

Interventions

Berzosertibdrug

Given IV

Cisplatindrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV