Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Bladder Cancer; Transitional Cell Carcinoma of the Urothelial Tract; Bladder Neoplasms

Treatments: Drug: vinflunine and best supportive care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00315237

L0070 IN 302 P1

CA183004

Details and patient eligibility

About

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.

Enrollment: 364 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bladder cancer
• Progressed after 1st line platinum-chemotherapy
• >= 18 years old
• Adequate hematologic, hepatic & renal function

Exclusion criteria

• CNS disease
• Moderate neuropathy
• More than 1 previous chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: vinflunine and best supportive care

2

No Intervention group

Description:

best supportive care for 18 week duration