Ispinesib In Combination With Capecitabine In Patients With Solid Tumors
- Conditions
- Solid Tumor Cancer
- Registration Number
- NCT00119171
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Plasma levels for SB-715992 and Capecitabine will be checked at Day 1 for Cycle 1.
- Secondary Outcome Measures
Name Time Method - Medical history at screening - ECOG Performance Status, Physical Exam, vitals, & labs done at screening, Week 1 (each cycle), & follow-up (f/u) - Continuous Adverse Event monitoring throughout the study
Trial Locations
- Locations (1)
GSK Investigational Site
πΊπΈSan Antonio, Texas, United States