NCT00535522

A Safety and Pharmacokinetic Study of TAK-285 in Patients With Advanced Cancer

A Multicenter, Open-Label, Noncomparative Phase I Clinical and Pharmacokinetic Study of Oral TAK-285 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and pharmacokinetics of TAK-285 in patients with advanced cancer.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	TAK-285 Dose Escalation Cohorts	TAK-285 50 mg tablet, orally, once or twice daily for three weeks, followed by seven days off. Dose escalation to maximum tolerated dose, with possibility of continuous dosing per cycle (daily dosing for four weeks without a break between cycles).
DRUG	TAK-285 Recommended Phase 2 Dosing Cohort	Expanded cohort with dose and regimen dependent upon the safety profile of the maximally tolerated dose and schedule determined in the dose escalation phase of the study.

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-09-26
• Last updated: 2011-12-09

Locations

3 sites across 1 country: United States