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

A Phase 1 study testing BAY 1841788(ODM-201) in people with Prostatic Neoplasms, run by Bayer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: BAY 1841788(ODM-201)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteJapan
Study dates: 23 Feb 2015to 18 Jan 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

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

Read the detailed description

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

Conditions: Prostatic Neoplasms
Being tested: BAY 1841788(ODM-201)
Keywords: Neoplasm Metastasis, Metastatic castration-resistant prostate cancer, Castration-resistant prostate cancer (CRPC)
Medical subject headings: Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02363855
Study group	Role	What they receive
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 Receives: Drug: BAY 1841788(ODM-201)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerability
Measured: 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)
Measured: Up to 12 weeks
Plasma concentration of BAY 1841788 characterized by Cmax
Cmax: maximum drug concentration in plasma after single dose administration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)}
Measured: 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
Measured: 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)}

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 201518 Jan 2018

First posted16 Feb 2015 (estimated)
Study start23 Feb 2015
Primary completion19 Nov 2015
Study completion18 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02363855
Sponsor's protocol ID: 17719
Status last verified: Jan 2018
First submitted: 10 Feb 2015
Last updated: 25 Jan 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02363855
Acronym / sponsor ID: 17719
Conditions: Prostatic Neoplasms
Keywords: Neoplasm Metastasis, Metastatic castration-resistant prostate cancer, Castration-resistant prostate cancer (CRPC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 23 Feb 2015 (actual)
Primary completion: 19 Nov 2015 (actual)
Study completion: 18 Jan 2018 (actual)
First posted: 16 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BAY 1841788(ODM-201)	Experimental	Drug: 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

Who may qualify

Ages: 20 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1
Life expectancy of at least 3 months

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	BAY 1841788(ODM-201)

Primary outcome

Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerability
Time frame: Up to 12 weeks
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)
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
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
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
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
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
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
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
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
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
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
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)}
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY 1841788(ODM-201) in people with Prostatic Neoplasms, run by Bayer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment Emergent Adverse Event as measure of safety and tolerability (time frame: Up to 12 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02363855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.