MedTrace Logo

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

NCT02300610 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Bladder Cancer
  • Carcinoma, Transitional Cell
  • Renal Pelvis Cancer
  • Ureter Cancer
  • Urethra Cancer

Interventions

DRUG

Enzalutamide

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

DRUG

Cisplatin

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

DRUG

Gemcitabine

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

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jingsong Zhang, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

  • Shilpa Gupta, M.D. · University of Minnesota Masonic Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-11
Primary Completion
2017-08-07
Completion
2019-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300610 on ClinicalTrials.gov