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

NCT00569153 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2016-04-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-01-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00569153 on ClinicalTrials.gov