Clinical trial NCT01084655 (phase 1/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, docetaxel, prednisone
SMILES: CNC(=O)C1=CC=C2C=C(C=CC2=C1)[C@@]1(O)CCN2C=NC=C12, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
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