Phase 1 Dose Escalation Study of BAY 1841788 in Japanese Metastatic Castration-resistant Prostate Cancer (mCRPC) Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02363855
• Date of registration: 10/02/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Phase 1 Dose Escalation Study of BAY 1841788 in Japanese Metastatic Castration-resistant Prostate Cancer (mCRPC) Subjects
• Scientific title: 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
• Date of first enrolment: February 23, 2015
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02363855
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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-a 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



Age minimum: 20 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Drug: BAY 1841788(ODM-201)

Primary Outcome(s)

Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerability [Time Frame: Up to 12 weeks]

Plasma concentration of BAY 1841788 characterized by AUC(0-12) [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of BAY 1841788 characterized by tmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of diastereomers BAY 1896952 characterized by tmax [Time Frame: tmax: time to reach maximum drug concentration in plasma after single (first) dose]

Plasma concentration of diastereomers BAY 1896951 characterized by AUC(0-12) [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of metabolite BAY 1896953 characterized by tmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of BAY 1841788 characterized by Cmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of diastereomers BAY 1896951 characterized by tmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

The intensity of an adverse event graded using the NCI CTCAE version 4.03 [Time Frame: Up to 12 weeks]

Plasma concentration of metabolite BAY 1896953 characterized by AUC(0-12) [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of diastereomers BAY 1896951 characterized by Cmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of diastereomers BAY 1896952 characterized by AUC(0-12) [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of diastereomers BAY 1896952 characterized by Cmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Plasma concentration of metabolite BAY 1896953 characterized by Cmax [Time Frame: Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}]

Secondary ID(s)

17719

Source(s) of Monetary Support

Please refer to primary and secondary sponsors