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)
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