CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Enzalutamide +2 moredrug
Likely dose
Enzalutamide 80 mgfrom 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/NCT02300610
NCT02300610Phase 1Completed
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A Phase I/1b Study of Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Nov 25, 2014·Updated Aug 1, 2019

In Brief

A Phase 1 clinical trial evaluating Enzalutamide, Cisplatin, and 1 other intervention for Bladder Cancer and 4 related conditions. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer, Carcinoma, Transitional Cell, Renal Pelvis Cancer, Ureter Cancer, Urethra Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 25, 2014
Enrollment StartFeb 11, 2015
Primary CompletionAug 7, 2017
Study CompletionApr 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.6 years ago

Interventions

Enzalutamidedrug

Enzalutamide orally once a day. Dose Escalation Level 1: 80 mg; Level 2: 160 mg. Dose Expansion at recommended dose level, after dose escalation.

Cisplatindrug

Cisplatin at 70 mg/m\^2 IV on day 1, repeated every 21 days for total of 6 cycles.

Gemcitabinedrug

Gemcitabine at 1000 mg/m\^2 IV on days 1, 8, repeated every 21 days for total of 6 cycles.