MedPath

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

Phase 1
Completed
Conditions
Prostatic Neoplasms
Interventions
Drug: BAY 1841788(ODM-201)
Registration Number
NCT02363855
Lead Sponsor
Bayer
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.

Detailed Description

The drug product is licensed from Orion pharma, Finland which is also the manufacturer of the product.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
9
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.

Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
BAY 1841788(ODM-201)BAY 1841788(ODM-201)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
Primary Outcome Measures
NameTimeMethod
Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerabilityUp to 12 weeks
The intensity of an adverse event graded using the NCI CTCAE version 4.03Up to 12 weeks

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

Plasma concentration of BAY 1841788 characterized by tmaxDay -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 BAY 1841788 characterized by AUC(0-12)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)}

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

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

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

Plasma concentration of BAY 1841788 characterized by CmaxDay -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)}

Cmax: maximum drug concentration in plasma after single dose administration

Plasma concentration of metabolite BAY 1896953 characterized by tmaxDay -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 1896951 characterized by CmaxDay -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)}

Cmax: maximum drug concentration in plasma after single dose administration

Plasma concentration of diastereomers BAY 1896951 characterized by AUC(0-12)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)}

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

Plasma concentration of metabolite BAY 1896953 characterized by CmaxDay -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)}

Cmax: maximum drug concentration in plasma after single dose administration

Plasma concentration of diastereomers BAY 1896952 characterized by tmaxtmax: 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)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)}

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

Plasma concentration of diastereomers BAY 1896951 characterized by tmaxDay -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 CmaxDay -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)}

Cmax: maximum drug concentration in plasma after single dose administration

Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy