Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium (JASINT1)

NCT01599013 Phase 2 COMPLETED

This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.

Details

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 2
Status	COMPLETED
Enrolment	69
Start date	2011-02
Completion	2014-04

Conditions

• Bladder Transitional Cell Carcinoma Stage IV

Interventions

• Vinflunine, Gemcitabine
• Vinflunine, Carboplatin

Primary outcomes

• Disease control rate as defined by RECIST criteria (version 1.1) as a percentage of best overall responses of Complete (CR) + Partial (PR) + Stable Disease (SD) for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations — Change from baseline in tumor assessment at 12 weeks (cycle 4)
  Assessment of lesions (measurable and non-measurable) should be performed at baseline and every 6 weeks (assessment interval). Evaluable patients: all baseline lesions must have been assessed at least once after the second cycle (6 weeks); patients who progress before the first evaluation will be considered as early progression. Primary analysis is planned on the intent to treat population, secondary analysis being performed on the evaluable population.

Countries

France