Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors
Status:
Completed
Trial end date:
2010-06-30
Target enrollment:
Participant gender:
Summary
A multi-center, open-label, two-arm, dose-escalation study to establish the safety,
tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in
adult subjects with advanced solid tumors that have relapsed, are refractory to standard
therapy, or for whom there is no standard therapy available.
The two dosing regimens to be evaluated are:
- Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
- Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)
When one of the two arms reaches MTD, all future subjects will then be enrolled in the
remaining study arm until MTD of that arm is reached.