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Completed

NCT Number: NCT02363855

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa, Chiba, 277-8577, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 weeks

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

  3. 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)}

    Cmax: maximum drug concentration in plasma after single dose administration

  4. 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)}

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

  5. 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)}

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

  6. 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)}

    Cmax: maximum drug concentration in plasma after single dose administration

  7. 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)}

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

  8. 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)}

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

  9. 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)}

    Cmax: maximum drug concentration in plasma after single dose administration

  10. 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)}

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

  11. 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)}

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

  12. 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)}

    Cmax: maximum drug concentration in plasma after single dose administration

  13. Plasma concentration of diastereomers BAY 1896952 characterized by tmax

    Time frame: 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)}

  14. 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)}

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2018
First posted
Feb 16, 2015
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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