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

Millennium Pharmaceuticals

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Prostatic Neoplasms

Prostate Cancer

Treatments

Drug: TAK-448

Drug: Leuprorelin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01132404

2009-017668-18 (EudraCT Number)

C18002

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

40 to 72 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Male 40 to 72 years of age
Histologically-confirmed adenocarcinoma of the prostate having completed primary local treatment at least 6 months prior to screening
Meet all laboratory evaluation values at screening as specified in protocol
For phase 1 of the study only: Concurrent gonadotropin releasing hormone (GnRH) therapy with generally indolent or stable disease OR a potential candidate of GnRH at some time in the future. Patients with metastatic disease must be asymptomatic with only bone scan positive evidence of metastases. Patients with recurrent local disease will be asymptomatic without bladder, bowel or obstructive symptoms
For 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 GnRH analog therapy.
Provision of informed consent and for the phase 1 portion of the study only, willing to participate 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
Ability to understand and comply with protocol requirements
Agreement to, even if surgically sterilized but not surgically castrated, practice effective barrier contraception OR abstain from heterosexual intercourse
Suitable venous access for blood sampling

Exclusion criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in either the phase 1 or phase 2 portion of the study:

Advanced or symptomatic metastatic prostate cancer requiring immediate GnRH or additional hormone therapy or requiring chemotherapy
History of surgical castration
History of nonskin cancer, other than prostate cancer, requiring active treatment within 2 years of screening
History of cardiac surgery, within the previous 6 months or any planned elective surgeries, other than skin surgery, during the ensuing 6 months
Compromise of bone marrow function that would reduce tolerance to repeated blood draws
History of osteoporosis, unless actively controlled with treatment, or history of vertebral or femoral fracture within the past year
History of seizures or currently on anticonvulsant medications
History of major psychiatric illness (diagnosed psychosis or psychiatric illness requiring hospitalization)
History of drug or significant alcohol abuse
Participation in clinical trials or receipt of experimental therapy within 2 months of screening
Serious infection within 14 days before first dose of study drug
Known history of human immunodeficiency (HIV) infection, hepatitis B, or hepatitis C infection
History of significant cardiovascular condition

In addition, for the phase 2 portion of the study, patients must not have any of the following exclusion criteria:

Participation in the phase 1 portion of the study
Prior or current use of a GnRH analog or androgen receptor antagonist as first-line hormone therapy (other than as neoadjuvant/adjuvant use)
History of use of GnRH analog or antagonist (as adjuvant or neoadjuvant therapy) within the 6 months prior to screening
History of known or documented primary failure of GnRH analog therapy
History of rising PSA or disease progression while on a GnRH analog or combined androgen blockade (CAB) therapy