NCT01132404 - Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

December 31, 2011

Conditions

Prostate CancerProstatic Neoplasms

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"

Trial Locations (1)

69437

Hôpital Edouard Herriot, 5, Place d'Arsonval, Pavillon V - Urologie et chirurgie de la transplantation, Lyon