NCT00569153

Safety Study of TAK-700 in Subjects With Prostate Cancer.

A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	TAK-700	Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments: * TAK-700 at 300 mg twice/day * TAK-700 at 400 mg and 5 mg prednisone twice/day * TAK-700 at 600 mg and 5 mg prednisone twice/day * TAK-700 at 600 mg once/day in the morning

Timeline

• Start date: 2008-04-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2007-12-06
• Last updated: 2016-04-04

Locations

19 sites across 1 country: United States