NCT00119171

Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	Ispinesib
DRUG	Capecitabine

Timeline

• Start date: 2004-11-01
• First posted: 2005-07-13
• Last updated: 2008-10-16

Locations

1 site across 1 country: United States