Clinical trial NCT01317641: Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
Collaborators: name: Endo Pharmaceuticals
First posted: 2011-03-17
Enrollment: 136
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
timeFrame: Up to 28 days for each cohort
measure: Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
timeFrame: Up to 28 days for each cohort
Secondary outcomes:
measure: Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
timeFrame: 3 months
measure: Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
timeFrame: 3 months
measure: Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
timeFrame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
measure: Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
timeFrame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
measure: Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
timeFrame: 1 day
measure: Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
timeFrame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
measure: Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
timeFrame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
measure: Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
timeFrame: 1 day
Other outcomes:
Locations:
city: Wheat Ridge
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Ocala
country: United States
facility: Urology Health Team PLLC
state: Florida
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Voorhees
country: United States
facility: Delaware Valley urology, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Hradec Králové
country: Czech Republic
facility: Klinika onkologie a radioterapie LFUK a FN
city: Olomouc
country: Czech Republic
facility: Fakultni Nemonicnice Olomouc
city: Znojmo
country: Czech Republic
facility: Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
city: Talinn
country: Estonia
facility: East-Tallinn Central Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Paris
country: France
facility: Saint Louis Hospital
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.