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

NCT02363855 | Completed Phase 1

• 1 other identifier: 17719
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

Neoplasm Metastasis; Metastatic castration-resistant prostate cancer; Castration-resistant prostate cancer (CRPC)

Outcome Measures

Primary Outcomes (14)

• Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerability

  Up to 12 weeks

• The intensity of an adverse event graded using the NCI CTCAE version 4.03

  National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE)

  Up to 12 weeks

• Plasma concentration of BAY 1841788 characterized by Cmax

  Cmax: maximum drug concentration in plasma after single dose administration

  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

  tmax: time to reach maximum drug concentration in plasma after single (first) dose

  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 AUC(0-12)

  AUC(0-12):AUC from time 0 to 12 hours after administration

  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

  Cmax: maximum drug concentration in plasma after single dose administration

  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

  tmax: time to reach maximum drug concentration in plasma after single (first) dose

  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 AUC(0-12)

  AUC(0-12):AUC from time 0 to 12 hours after administration

  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

  Cmax: maximum drug concentration in plasma after single dose administration

  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

  tmax: time to reach maximum drug concentration in plasma after single (first) dose

  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 AUC(0-12)

  AUC(0-12):AUC from time 0 to 12 hours after administration

  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

  Cmax: maximum drug concentration in plasma after single dose administration

  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

  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)}

  tmax: time to reach maximum drug concentration in plasma after single (first) dose

• Plasma concentration of diastereomers BAY 1896952 characterized by AUC(0-12)

  AUC(0-12):AUC from time 0 to 12 hours after administration

  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)}

Study Arms (1)

BAY 1841788(ODM-201)

EXPERIMENTAL

Cohort 1: Safety, tolerability and PK of 300 mg dose given twice daily. Escalation to cohort 2 in case no safety relevant adverse event has been observed within 28 days after start of multiple dose (MD) Cohort 2: Safety, tolerability and PK of 600 mg dose given twice daily

Drug: BAY 1841788(ODM-201)

Interventions

BAY 1841788(ODM-201) DRUG

Cohort 1: Single dose 300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks Cohort 2: Single dose 2x300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks.

BAY 1841788(ODM-201)

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 16, 2015
• Study Start: February 23, 2015
• Primary Completion: November 19, 2015
• Study Completion: January 18, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

JP (1)