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