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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317641
• Other study ID #: 3104001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 7, 2011
• Last updated: October 20, 2014
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2014
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeFinland: Finnish Medicines AgencyFinland: Ethics CommitteeCzech Republic: State Institute for Drug ControlCzech Republic: Ethics CommitteeUnited States: Institutional Review BoardUnited States: Food and Drug AdministrationEstonia: Research Ethics CommitteeEstonia: The State Agency of Medicine
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ODM-201
ODM-201 administered orally daily

Locations

Country	Name	City	State
Czech Republic	Klinika onkologie a radioterapie LFUK a FN	Hradec Králové
Czech Republic	Fakultni Nemonicnice Olomouc	Olomouc
Czech Republic	Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo	Znojmo
Estonia	East-Tallinn Central Hospital	Talinn
Finland	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
France	Saint Louis Hospital	Paris
France	Institut Gustave Roussy	Villejuif
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Velindre Cancer Centre	Cardiff
United Kingdom	Christie Hospital	Manchester
United Kingdom	Churchill Hospital	Oxford
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Eastern CT Hematology and Oncology Associates	Norwich	Connecticut
United States	Urology Health Team PLLC	Ocala	Florida
United States	Delaware Valley urology, LLC	Voorhees	New Jersey
United States	The Urology Center of Colorado	Wheat Ridge	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma	Endo Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czech Republic,  Estonia,  Finland,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination		3 months	Yes
Secondary	Pharmacokinetics of ODM-201 and its major metabolite		28 days	No
Secondary	Response in prostate specific antigen (PSA) and in soft and bone tissues		3 months	No

External Links

•   Lancet Oncology publication containing study results
•   PubMed link to the Lancet Oncology publication containing study results