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 sites123 target enrollmentSeptember 7, 2010

DrugsEligard 7.5mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Millennium Pharmaceuticals, Inc.
Enrollment: 123
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 7, 2010

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•\-Male 40 to 78 years of age, inclusive, in phase 1; no upper age limit for phase 2, if medical entry criteria are otherwise met.
•\-Histologically confirmed adenocarcinoma of the prostate, having completed primary local treatment at least 6 months prior to screening.
•\-Screening serum PSA concentration \> 2 ng/mL, unless the patient is on concurrent (or intermittent) GnRH analog therapy, in which case no lower limit is applicable (phase 1\).
•\-For single\-dose portion only: Either
•a.Concurrent GnRH therapy (which may include patients on intermittent GnRH therapy or patients who are otherwise between injections of GnRH analog therapy) with generally indolent or stable disease with PSA DT \> 4 months and absolute PSA \< 200 ng/mL and, if metastatic disease is present, asymptomatic with only bone scan positive and/or lymph node evidence of metastases. Patients with recurrent local disease will be generally asymptomatic, without bladder, bowel, or obstructive symptoms.
•b.If not receiving GnRH therapy, a potential candidate for GnRH at some time in the future (ie, in a period of ‘watchful waiting,’ with generally indolent or stable disease and with PSA DT \> 3 months and absolute PSA \< 200 ng/mL, and, if metastatic disease, asymptomatic, with only bone scan positive and/or lymph node evidence of metastases). Patients with recurrent local disease will be generally asymptomatic, without bladder, bowel, or obstructive symptoms.
•\-For the multiple\-dose portion 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 GnRH analog therapy. Patients are not eligible for inclusion if they are to receive first line hormone therapy as adjuvant/neoadjuvant therapy for local treatment of disease (surgery or radiation) or for primary local tumor control.
•\-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 as adjuvant/neoadjuvant therapy for local treatment of disease (surgery or radiation) or for primary local tumor control.
•\-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.
•\-Generally fit medical condition, with no acute or chronic medical conditions, other than prostate cancer, affecting 2 year life expectancy.

Exclusion Criteria

•\-Advanced or symptomatic metastatic prostate cancer requiring immediate GnRH or additional hormone (CAB) therapy or requiring chemotherapy
•\-History of surgical castration
•\-Any history of nonskin cancer, other than prostate cancer, requiring active treatment within the 2 years prior to screening
•\-Any history of cardiac surgery, within the previous 6 months or any planned elective surgeries, other than skin surgery, during the ensuing 6 months
•\-Any compromise of bone marrow function that would reduce tolerance to repeated blood draws
•\-Any history of osteoporosis, unless actively controlled with treatment, or history of vertebral or femoral fracture within the past year
•\-Any history of seizures or currently on anticonvulsant medications
•\-Any history of major psychiatric illness (eg, diagnosed psychosis or psychiatric illness requiring hospitalization within the previous year)
•\-Any history of drug or significant alcohol abuse
•\-Any participation in clinical trials or receipt of any experimental therapy within 2 months of screening, with the exception of participation in the phase 1 single\-dose portion of this study