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Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma

NCT00461851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-12-14

Study results available
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Summary

This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.

DRUG

Carboplatin

Carboplatin will be given on day 1 to an AUC of 5.

DRUG

Sorafenib

Sorafenib will be administered orally daily on days 2-19 at 400 mg bid

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Hari Deshpande, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00461851 on ClinicalTrials.gov