A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
- Registration Number
- NCT00259935
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Inclusion Criteria
- Subjects with advanced solid tumors.
- At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
- Subjects must be free of post-treatment side effects.
Exclusion Criteria
- Women who are pregnant or lactating
- Subjects with uncontrolled emesis, regardless of etiology, active infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description All treated subjects topotecan Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.
- Primary Outcome Measures
Name Time Method Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2. Days 1, 8
- Secondary Outcome Measures
Name Time Method Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1 Up to 38 days
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇱Utrecht, Netherlands