Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen

Phase 2

Completed

Brief Summary: This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).

Recruitment & Eligibility

Inclusion Criteria

Each patient must meet all of the following inclusion criteria:

Male patients 18 years or older
Eastern Cooperative Oncology Group performance status 0-2
Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.
Voluntary written consent
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone
Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months
Has undergone orchiectomy or will continue receiving GnRH analogue therapy
Meet screening laboratory values as specified in protocol

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Known hypersensitivity to TAK-700 or related compounds
Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids
Received prior therapy with aminoglutethimide or ketoconazole
Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
Received prior chemotherapy for prostate cancer
Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis
Symptoms that investigator deems related to prostate cancer
Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
History of adrenal insufficiency
Uncontrolled cardiovascular condition
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
Unwilling or unable to comply with protocol
Major surgery or serious infection within 14 days of first dose of TAK-700
Life-threatening illness unrelated to cancer
Uncontrolled nausea, vomiting or diarrhea
Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700

Arm && Interventions

Group	Intervention	Description
TAK-700	TAK-700	-

Primary Outcome Measures

Name	Time	Method
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment	3 months

Secondary Outcome Measures

Name	Time	Method
To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months	3 and 6 months
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment	6 months
To determine time to PSA progression, time to metastases, and duration of progression-free survival	Evidence of PSA or disease progression
To monitor changes in endocrine markers	Evidence of PSA or disease progression
To evaluate the safety of TAK-700	Evidence of PSA or disease progression

Locations (3): Oregon Health and Sciences University
🇺🇸
Portland, Oregon, United States
University of Wisconsin Hospitals and Clinics
🇺🇸
Madison, Wisconsin, United States
University of Michigan Comprehensive Cancer Center
🇺🇸
Ann Arbor, Michigan, United States