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Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel

NCT01668459 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-12-04

No results posted yet for this study

Summary

A study for patients with confirmed locally advanced or metastatic Transitional Cell Carcinoma of the bladder or upper urinary tracts who have developed progressive disease within 12 months of their platinum based chemotherapy. The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy.

Conditions

  • Transitional Cell Carcinoma

Interventions

DRUG

Cabazitaxel

25 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: maximum 6

OTHER

Best Supportive Care

Best Supportive Care including single agent chemotherapy as determined by the patient's study physician

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Dr Anjali Zarkar

    lead OTHER

Principal Investigators

  • Anjali Zarkar · University Hospitals Birmingham NHS FT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01668459 on ClinicalTrials.gov