NCT00765973

Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors

A Phase 1 Study of Topotecan Liposomes Injection (TLI) in Subjects With Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will utilize an accelerated design with small initial cohort sizes that allow fewer subjects to be enrolled at sub-therapeutic doses such as the very low starting doses in both arms of the study. Initial cohorts will include only one subject and dose escalations will be in 100% increments until a single Grade 2 toxicity related to study drug or DLT occurs in Cycle 1. Dose escalation will proceed until the MTD is exceeded. MTD is defined as average of the highest dose level for which 2 out of 6 subjects experience a DLT and the previous dose level, provided no additional DLTs occur. Subjects who discontinue TLI treatment before completion of Cycle 1 for reasons other than toxicity will not be evaluable for the determination of MTD and will be replaced. The study will consist of a screening period, treatment period, and a post-treatment period. Subjects will be followed for 30 days after their last TLI dose. Safety and tolerability parameters include clinical laboratory assessments, vital signs, physical examinations, and adverse events (AEs).

Conditions

• Small Cell Lung Cancer
• Ovarian Cancer
• Solid Tumors

Interventions

Type	Name	Description
DRUG	Topotecan Liposomes Injection (TLI)	TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
DRUG	Topotecan Liposomes Injection (TLI)	TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)

Timeline

• Start date: 2008-11-10
• Primary completion: 2010-06-30
• Completion: 2010-06-30
• First posted: 2008-10-03
• Last updated: 2020-11-13

Locations

2 sites across 1 country: United States