Clinical trial NCT01046916 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: tak-700
SMILES: CNC(=O)C1=CC=C2C=C(C=CC2=C1)[C@@]1(O)CCN2C=NC=C12
Eligibility criteria:

        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