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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
GSK Investigational Site
San Antonio, Texas, United States
Plasma levels for SB-715992 and Capecitabine
Time frame: will be checked at Day 1 for Cycle 1.
- Medical history
Time frame: at screening
- ECOG Performance Status, Physical Exam, vitals, & labs
Time frame: done at screening, Week 1 (each cycle), & follow-up (f/u)
- Continuous Adverse Event monitoring
Time frame: throughout the study
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