NCT01315431

A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Tesetaxel plus capecitabine	Study medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14. At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2011-03-15
• Last updated: 2012-07-24

Locations

1 site across 1 country: United States