Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

• Voluntary written consent
• Male patients 18 years or older
• Estimated life expectancy of 6 months or more
• Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
• Radiograph-documented metastatic disease
• Progressive disease
• Prior surgical castration or concurrent use of an agent for medical castration
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Physical examination findings that are consistent with other study entry or exclusion criteria and identified but not excluded chronic conditions
• Even if surgically sterilized, patients must Practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug, OR Abstain from heterosexual intercourse
• Any use of opiates must be stable for at least 2 weeks prior to study entry
• Meet screening laboratory values as specified in protocol
• Suitable venous access

Exclusion Criteria:

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

• Known hypersensitivity to TAK-700, docetaxel, prednisone or related compounds
• Received any of the following within 30 days prior to the first dose of TAK-700: prior therapy with any investigational compound; prior herbal product known to decrease PSA; OR radiation therapy for prostate cancer
• Received prior therapy with TAK-700, aminoglutethimide, ketoconazole or abiraterone (for Phase 1 only, patients previously treated with ketoconazole or abiraterone will be eligible if treatment with ketoconazole or abiraterone was discontinued at least 30 days prior to enrollment)
• 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 spinal cord compression, bilateral hydronephrosis or neck outlet obstruction
• 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
• Uncontrolled cardiovascular condition
• New York Heart Association Class (NYHA) Class III or IV
• Uncontrolled hypertension despite medical therapy
• 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