CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Olaparibdrug
Likely dose
Olaparib 40 mLfrom 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/NCT03448718
NCT03448718Phase 2Completed
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Phase 2 Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations

Matthew Galsky·interventional·Posted Feb 28, 2018·Updated Nov 22, 2023

In Brief

A Phase 2 clinical trial evaluating Olaparib for Metastatic Urothelial Cancer. Completed, enrolled 19 participants across 7 sites.

Detailed Summary

This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per RECIST 1.1) to treatment with olaparib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Urothelial Cancer
CountriesUnited States
CollaboratorsIcahn School of Medicine at Mount Sinai, AstraZeneca

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartApr 17, 2018
Primary CompletionJul 14, 2021
Study CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.3 years ago

Interventions

Olaparibdrug

1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.