Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies
- Registration Number
- NCT00669097
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TKI258 TKI258 -
- Primary Outcome Measures
Name Time Method Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites Day 15 Cohort 2: Safety and Tolerability of TKI258 Time to patient withdrawal due to disease progression or tolerability issues
- Secondary Outcome Measures
Name Time Method Cohort 1: Safety and tolerability of TKI258 Time to patient withdrawal due to disease progression or tolerability issues Cohort 1: Preliminary anti-tumor activity of TKI258 Time to tumor progression Preliminary Anti-tumor activity of TKI258 Time to tumor progression
Trial Locations
- Locations (1)
Novartis Investigative Site
🇳🇱Amsterdam, Netherlands