study of tak-700 in combination with docetaxel and prednisone in men with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

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).


Eligibility 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