Phase 1 dose escalation study of BAY 1841788 in Japanese metastatic castration-resistant prostate cancer (mCRPC) subjects
The primary objectives of this study are to investigate the safety and tolerability of BAY 1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC) and the PK of BAY 1841788 and its major metabolite BAY 1896953.
- 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.
- 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
Kashiwa, Japan, 277-8577
E-mail: [email protected]
Phone: (+) 1-888-8422937
An open label Phase I study to evaluate the safety, tolerability and pharmacokinetics of BAY 1841788 in Japanese subjects with metastatic castration-resistant prostate cancer
Single Group Assignment