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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2 Multicenter Open-label Study Evaluating the Safety and Efficacy of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer (CRPC) and a Rising Prostate-specific Antigen (PSA)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: TAK-700


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-700<br> | Drug: TAK-700<br>* TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |