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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Docetaxel; Prednisone

Criteria

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