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Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448

NCT01132404 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2012-01-31

No results posted yet for this study

Summary

The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The phase 2 portion of this study is an open-label, multicenter, randomized study in men with prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)- lowering potential of up to 2 dose levels of 1-month depot TAK-448.

Conditions

Interventions

DRUG

Leuprorelin

Phase 2 portion of study: patients randomized to this arm will receive a subcutaneous injection of depot Leuprorelin in the abdomen once per month for up to 6 months

DRUG

TAK-448

Phase 1 portion of study: Patients will be administered a single dose of depot formulation TAK-448 via subcutaneous abdominal injection and a single dose of placebo at a contralateral injection site Phase 2 portion of the study: Patients randomized to this arm will be administered depot formulation TAK-448 (up to 2 dose levels) via subcutaneous injection in the abdomen once per month for up to 6 months

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
72 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01132404 on ClinicalTrials.gov