Trial Condition(s):

Prostatic Neoplasms

Phase 1 dose escalation study of BAY 1841788 in Japanese metastatic castration-resistant prostate cancer (mCRPC) subjects

Bayer Identifier:

17719

ClinicalTrials.gov Identifier:

NCT02363855

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
9
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 

Trial Design