Clinical trial NCT02363855 (phase 1, status: completed)
Conditions: prostatic neoplasms
ICD codes: B38.81, N42.31, Z87.430, N40.0, N40.1
Drugs: bay 1841788(odm-201)
SMILES: C[C@@H](CN1C=CC(=N1)C1=CC=C(C#N)C(Cl)=C1)NC(=O)C1=NNC(=C1)C(C)O
Eligibility criteria:

        Inclusion Criteria:

          -  Japanese males aged ≥ 20 years

          -  Histologically or cytologically confirmed adenocarcinoma of prostate without
             neuroendocrine differentiation or small cell features

          -  Patients with metastatic castration-resistant prostate cancer (mCRPC). CRPC is defined
             as follows

               -  Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone
                  (LHRH) analogue or antagonist, or bilateral orchiectomy, and castrate level of
                  serum testosterone (< 1.7 nmol/l [50 ng/dL]) at screening AND

               -  Progressive disease and/or prostate-specific antigen (PSA) increase of three
                  consecutive rises, at least 1 week apart AND

               -  PSA > 2ng/mL at screening

          -  Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1

          -  Life expectancy of at least 3 months

          -  Blood counts at screening: haemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥
             1,500/μL (1.5x109/l), platelet count ≥ 100,000/μL (100x109/l) (patient must not have
             received any growth factor or blood transfusion within 7 days of the hematology
             laboratory obtained at screening)

          -  Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase
             (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤
             1.5 x ULN, albumin > 3.0 g/dl

          -  Prior treatment with antiandrogen. Discontinuation of bicalutamide or nilutamide (not
             approved in Japan) at least 6 weeks and other antiandrogens at least 4 weeks prior to
             the start of the study drug administration.

        Exclusion Criteria:

          -  Known metastases in the brain

          -  Symptomatic local-regional disease that requires medical intervention including
             moderate/severe urinary obstruction or hydronephrosis due to prostate cancer

          -  Acute toxicities (except for alopecia and CTCAE grade 2 neuropathy) of prior
             treatments and procedures not resolved to CTCAE ≤ grade 1 or baseline before the first
             drug administration

          -  Febrile neutropenia of Common Terminology Criteria for Adverse Events (CTCAE) ≥ 3

          -  History of other malignancy within the previous 5 years except a basal cell carcinoma
             of skin and any other cancer for which treatment has been completed ≥ 5 years ago and
             from which the patient has been disease-free5 years ago and from which the patient has
             been disease-free

          -  Prior treatment within 4 weeks before the first drug administration with
             immunotherapy, antiandrogen, CYP17 inhibitor (CYP17i), oral ketoconazole, estrogens,
             5-α reductase inhibitors or investigational treatment

          -  Use of bicalutamide or nilutamide (not approved in Japan) within 6 weeks before the
             first drug administration

          -  Radiation therapy (external beam radiation therapy [EBRT], brachytherapy, or
             radiopharmaceuticals) or chemotherapy (except for nitrosoureas and mitomycin C) within
             4 weeks before the first drug administration. Use of nitrosoureas or mitomycin C
             within 6 weeks before the first drug administration.

          -  Prior use of any herbal products known to decrease PSA levels (e.g. PC SPES or saw
             palmetto) within 4 weeks before the first drug administration