Prostate CancerPhase 1/2NCT01317641

Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

A Phase 1/2 study testing ODM-201 in people with Prostate Cancer, run by Orion Corporation, Orion Pharma at 23 sites in 6 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: ODM-201
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 23 sitesin 6 countries
Study dates: Mar 2011to Jul 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Written informed consent
Histologically confirmed adenocarcinoma of prostate
Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
Progressive metastatic disease
Adequate bone marrow, hepatic, and renal function

Who cannot join

Known metastases in the brain
History of other malignancy within the previous 5 years
Known gastrointestinal disease or procedure that affects the absorption
Not able to swallow the study drug

Trial locations and contacts

23 sites in 6 countries.

Country

City, postcode or hospital

23 sites in 6 countries

United States8 sites

Chesapeake Urology Research Associates
Baltimore, Maryland, 21327
Brooklyn Urology Research Group
Brooklyn, New York, 11215
Cleveland Clinic
Cleveland, Ohio, 44195
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360
Urology Health Team PLLC
Ocala, Florida, 34474
Delaware Valley urology, LLC
Voorhees Township, New Jersey, 08043
The Urology Center of Colorado
Wheat Ridge, Colorado, 80211

Other trials in United States

Finland5 sites

Helsinki University Central Hospital
Helsinki
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku

Other trials in Finland

United Kingdom4 sites

Queen Elizabeth Hospital
Birmingham
Velindre Cancer Centre
Cardiff
Christie Hospital
Manchester
Churchill Hospital
Oxford

Other trials in United Kingdom

Czechia3 sites

Klinika onkologie a radioterapie LFUK a FN
Hradec Králové
Fakultni Nemonicnice Olomouc
Olomouc
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
Znojmo

Other trials in Czechia

France2 sites

Saint Louis Hospital
Paris
Institut Gustave Roussy
Villejuif

Other trials in France

Estonia1 site

East-Tallinn Central Hospital
Talinn

Other trials in Estonia

About this study

Official title: Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Conditions: Prostate Cancer
Being tested: ODM-201
Medical subject headings: Prostatic Neoplasms

What participants receive

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

ODM-201Drug
ODM-201 administered orally daily

Study groups in NCT01317641
Study group	Role	What they receive
ODM-201 Phase I	Experimental	Not described Receives: Drug: ODM-201
ODM-201 Phase II Dose 1	Experimental	Not described Receives: Drug: ODM-201
ODM-201 Phase II Dose 2	Experimental	Not described Receives: Drug: ODM-201
ODM-201 Phase II Dose 3	Experimental	Not described Receives: Drug: ODM-201

What is being measured

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

Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Measured: Up to 28 days for each cohort
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Measured: Up to 28 days for each cohort

Secondary outcomes (15)

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor
Measured: 3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor
Measured: 3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor
Measured: 3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Measured: 3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Measured: 3 months
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Measured: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Measured: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Measured: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Measured: 3 months
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
AUC(0-8h)
Measured: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
Measured: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
Measured: 1 day
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
AUC(0-8h)
Measured: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
Measured: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
Measured: 1 day

Timeline

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

Mar 2011Jul 2013

First posted17 Mar 2011 (estimated)
Study startMar 2011
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01317641
Sponsor's protocol ID: 3104001
Status last verified: Feb 2017
First submitted: 7 Mar 2011
Last updated: 29 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.
PubMed 24974051

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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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component
ClinicalTrials.gov ID: NCT01317641
Acronym / sponsor ID: 3104001
Conditions: Prostate Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
Collaborators: Endo USA Inc., a Keenova Therapeutics Company
Study start: Mar 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 17 Mar 2011 (estimated)
Results: Posted 29 Mar 2017

Clinical summary

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

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
ODM-201 Phase I	Experimental	Drug: ODM-201
ODM-201 Phase II Dose 1	Experimental	Drug: ODM-201
ODM-201 Phase II Dose 2	Experimental	Drug: ODM-201
ODM-201 Phase II Dose 3	Experimental	Drug: ODM-201

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Written informed consent
Histologically confirmed adenocarcinoma of prostate
Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
Progressive metastatic disease
Adequate bone marrow, hepatic, and renal function

Key exclusion criteria (4 listed)

Known metastases in the brain
History of other malignancy within the previous 5 years
Known gastrointestinal disease or procedure that affects the absorption
Not able to swallow the study drug

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
ODM-201ODM-201 administered orally daily	Drug	ODM-201 Phase I, ODM-201 Phase II Dose 1, ODM-201 Phase II Dose 2, ODM-201 Phase II Dose 3

Primary outcome

Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
Time frame: Up to 28 days for each cohort
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
Time frame: Up to 28 days for each cohort
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)

15 secondary outcomes

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Time frame: 3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Time frame: 3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Time frame: 3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Time frame: 3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Time frame: 3 months
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Time frame: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Time frame: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Time frame: 3 months
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Time frame: 3 months
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
Time frame: 1 day
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
Time frame: 1 day

Results and safety

Results posted to the registry on 29 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: ODM-201 200 mg/Day	4	3
Phase 1: ODM-201 400 mg/Day	7	6
Phase 1: ODM-201 600 mg/Day	3	3
Phase 1: ODM-201 1000 mg/Day	4	3
Phase 1: ODM-201 1400 mg/Day	3	3
Phase 1: ODM-201 1800 mg/Day	3	3
Phase 2: ODM-201 200mg/Day	38	35
Phase 2: ODM-201 400mg/Day	38	33
Phase 2: ODM-201 1400mg/Day	36	31

Primary outcome: Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)

Time frame: Up to 28 days for each cohort. Number. Unit: events

Measure	Phase 1: ODM-201 200 mg/Day n = 4	Phase 1: ODM-201 400 mg/Day n = 7	Phase 1: ODM-201 600 mg/Day n = 3	Phase 1: ODM-201 1000 mg/Day n = 4	Phase 1: ODM-201 1400 mg/Day n = 3	Phase 1: ODM-201 1800 mg/Day n = 3
Value	0	0	0	0	0	0

Population analysed: Safety population included all participants in Phase 1 who received any study drug.

Primary outcome: Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose

Time frame: Up to 28 days for each cohort. Number. Unit: DLTs

Measure	Phase 1: ODM-201 200 mg/Day n = 4	Phase 1: ODM-201 400 mg/Day n = 7	Phase 1: ODM-201 600 mg/Day n = 3	Phase 1: ODM-201 1000 mg/Day n = 4	Phase 1: ODM-201 1400 mg/Day n = 3	Phase 1: ODM-201 1800 mg/Day n = 3
Value	0	0	0	0	0	0

Population analysed: Safety population included all participants in Phase 1 who received any study drug.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, 200mg/Day ODM-201	0 of 4 (0%)	4 of 4 (100%)	Not reported
Phase 1, 400mg/Day ODM-201	2 of 7 (28.6%)	5 of 7 (71.4%)	Not reported
Phase 1, 600mg/Day ODM-201	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Phase 1, 1000mg/Day ODM-201	1 of 4 (25%)	4 of 4 (100%)	Not reported
Phase 1, 1400mg/Day ODM-201	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Phase 1, 1800mg/Day ODM-201	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Phase 2, 200mg/Day ODM-201	2 of 38 (5.3%)	33 of 38 (86.8%)	Not reported
Phase 2, 400mg/Day ODM-201	3 of 37 (8.1%)	35 of 37 (94.6%)	Not reported
Phase 2, 1400mg/Day ODM-201	4 of 35 (11.4%)	27 of 35 (77.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24974051Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.
PubMed link to the Lancet Oncology publication containing study resultsLink provided by the sponsor.

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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.

Karim Fizazi principal investigator

Gustave Roussy, Cancer Campus, Grand Paris

23 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ODM-201 in people with Prostate Cancer, run by Orion Corporation, Orion Pharma at 23 sites in 6 countries.

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 5 inclusion and 4 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Finland, United Kingdom, Czechia, France and 1 more country. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT) (time frame: Up to 28 days for each cohort). The study lists 2 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 NCT01317641, which also lists 1 linked publication.

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 29 Mar 2017.