NCT01048580

Study of Perifosine + Capecitabine for Colon Cancer Patients

A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Detailed description

This study is a Phase I trial. A total of 3 - 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine 50 mg orally once a day (Days 1-21)
DRUG	Capecitabine	Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-05-01
• Completion: 2011-10-01
• First posted: 2010-01-13
• Last updated: 2018-06-28