A Phase 1/2, Open-Label Study in Men with Prostate Cancer to Assess the Safety, Pharmacokinetics, and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1 Month Depot, Including a Randomized Portion With a Group Administered Leuprorelin

Millennium Pharmaceuticals, Inc.0 sites0 target enrollmentApril 2, 2010

ConditionsProstate cancer MedDRA version: 12.1Level: LLTClassification code 10007113Term: Cancer of prostate

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate cancer
Sponsor: Millennium Pharmaceuticals, Inc.
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 2, 2010

End Date

September 9, 2011

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•The following criteria must be met by each patient to be eligible for the phase 1 or phase 2 portion of the study, unless otherwise specified:
•1\. Male 40 to 72 years of age, inclusive.
•2\. Histologically\-confirmed adenocarcinoma of the prostate, having completed primary local treatment at least 6 months prior to screening.
•3\. Screening serum PSA concentration \> 2 ng/mL.
•4\. For the phase 1 portion of the study only: Either
•a) Concurrent GnRH therapy with generally indolent or stable disease with PSA DT \>6 months and absolute PSA \<30 ng/mL and if metastatic disease, asymptomatic with only bone scan positive evidence of metastases. Patients with recurrent local disease will be asymptomatic without bladder, bowel, or obstructive symptoms.
•b) If not receiving GnRH therapy, a potential candidate for GnRH at some time in the future, i.e. in a period of ‘watchful waiting’ with generally indolent or stable disease with PSA DT \>6 months and absolute PSA \<30 ng/mL, and if metastatic disease, asymptomatic with only bone scan positive evidence of metastases. Patients with
•recurrent local disease will be asymptomatic without bladder, bowel, or obstructive symptoms.
•5\. For the phase 2 portion of the study only: Evidence of progressive prostate cancer, which in the opinion of the referring physician and/or study investigator warrants the initiation of GnRH analog therapy. Such patients may have either elevated or rising PSA at least 6 months following primary local therapy(ies) or have evidence of metastatic disease not previously treated with first line hormone (GnRH analog) therapy. Patients are not eligible for inclusion if they are to receive first line hormone therapy for adjuvant/neoadjuvant therapy as part of local treatment of disease (surgery or radiation) or for primary local tumor control.
•6\. Provision of informed consent and, for the phase 1 portion of the study only, willing to participate in a phase 1 trial with no expectation of therapeutic benefit.

Exclusion Criteria

•1\. Advanced or symptomatic metastatic prostate cancer requiring immediate GnRH or
•additional hormone (CAB) therapy or requiring chemotherapy
•2\. History of surgical castration
•3\. Any history of nonskin cancer, other than prostate cancer, requiring active treatment within the 2 years prior to screening
•4\. Any history of cardiac surgery, within the previous 6 months or any planned elective surgeries, other than skin surgery, during the ensuing 6 months
•5\. Any compromise of bone marrow function that would reduce tolerance to repeated
•blood draws
•6\. Any history of osteoporosis, unless actively controlled with treatment, or history of
•vertebral or femoral fracture within the past year
•7\. Any history of seizures or currently on anticonvulsant medications