Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
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
1 other identifier
interventional
136
6 countries
23
Brief Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Mar 2011
Shorter than P25 for phase_1 prostate-cancer
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
March 29, 2017
CompletedMarch 29, 2017
February 1, 2017
2.3 years
March 7, 2011
March 23, 2016
February 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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)
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
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
3 months
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
3 months
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
3 months
- +10 more secondary outcomes
Study Arms (4)
ODM-201 Phase I
EXPERIMENTALODM-201 Phase II Dose 1
EXPERIMENTALODM-201 Phase II Dose 2
EXPERIMENTALODM-201 Phase II Dose 3
EXPERIMENTALInterventions
ODM-201 administered orally daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orion Corporation, Orion Pharmalead
- Endo Pharmaceuticalscollaborator
Study Sites (23)
The Urology Center of Colorado
Wheat Ridge, Colorado, 80211, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Urology Health Team PLLC
Ocala, Florida, 34474, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, 21327, United States
Delaware Valley urology, LLC
Voorhees Township, New Jersey, 08043, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11215, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Klinika onkologie a radioterapie LFUK a FN
Hradec Králové, Czechia
Fakultni Nemonicnice Olomouc
Olomouc, Czechia
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
Znojmo, Czechia
East-Tallinn Central Hospital
Talinn, Estonia
Helsinki University Central Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Saint Louis Hospital
Paris, France
Institut Gustave Roussy
Villejuif, France
Queen Elizabeth Hospital
Birmingham, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Christie Hospital
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Related Publications (1)
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.
PMID: 24974051DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Oncology
- Organization
- Orion Pharma, Development, R&D
Study Officials
- PRINCIPAL INVESTIGATOR
Karim Fizazi
Gustave Roussy, Cancer Campus, Grand Paris
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 17, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 29, 2017
Results First Posted
March 29, 2017
Record last verified: 2017-02