drugset / Trial / NCT00403429

MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

NCT00403429 ↗

Phase 2 Completed 36 enrolled National Cancer Institute, Naples
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.

Timeline

Start
2006-03
Primary completion
2008-01
Completion
2008-07

Outcome

Missed primary endpoint

paper The objective response rate was 3.1% [95% exact confidence interval (CI): 0.08-16.22%], lower than the threshold required to define the treatment as active. PMID 19266200 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1250 mg/m2 Oral

Indications