drugset / Trial / NCT00990912

A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)

NCT00990912

Phase 1/2 Completed 20 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.

Timeline

Start
2004-01
Primary completion
2005-11
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 2 unknown Intravenous
Comparator Irinotecan Small molecule 9 mg/m2 Intravenous
Comparator Irinotecan Small molecule 10 mg/m2 Intravenous
Comparator Irinotecan Small molecule 12 mg/m2 Intravenous
Comparator Irinotecan Small molecule 18 mg/m2 Intravenous