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

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ClinicalTrials.gov Identifier: NCT02363855
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: BAY 1841788(ODM-201) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 23, 2015
Actual Primary Completion Date : November 19, 2015
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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
Drug: BAY 1841788(ODM-201)
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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363855


Locations
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Japan
Kashiwa, Chiba, Japan, 277-8577
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02363855     History of Changes
Other Study ID Numbers: 17719
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Bayer:
Neoplasm Metastasis
Metastatic castration-resistant prostate cancer
Castration-resistant prostate cancer (CRPC)

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases