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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ODM-201
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Urology Center of Colorado
  • Eastern CT Hematology and Oncology Associates
  • Urology Health Team PLLC
  • Chesapeake Urology Research Associates
  • Delaware Valley urology, LLC
  • Brooklyn Urology Research Group
  • Cleveland Clinic
  • Carolina Urologic Research Center
  • Klinika onkologie a radioterapie LFUK a FN
  • Fakultni Nemonicnice Olomouc
  • Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
  • East-Tallinn Central Hospital
  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Saint Louis Hospital
  • Institut Gustave Roussy
  • Queen Elizabeth Hospital
  • Velindre Cancer Centre
  • Christie Hospital
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

ODM-201 Phase I

ODM-201 Phase II Dose 1

ODM-201 Phase II Dose 2

ODM-201 Phase II Dose 3

Arm Description

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

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
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
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
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.
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.
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.
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
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
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
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
AUC(0-8h)
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
AUC(0-8h)
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1

Full Information

First Posted
March 7, 2011
Last Updated
February 9, 2017
Sponsor
Orion Corporation, Orion Pharma
Collaborators
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01317641
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma
Collaborators
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ODM-201 Phase I
Arm Type
Experimental
Arm Title
ODM-201 Phase II Dose 1
Arm Type
Experimental
Arm Title
ODM-201 Phase II Dose 2
Arm Type
Experimental
Arm Title
ODM-201 Phase II Dose 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ODM-201
Intervention Description
ODM-201 administered orally daily
Primary Outcome Measure Information:
Title
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
Description
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.
Time Frame
Up to 28 days for each cohort
Title
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
Description
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Time Frame
Up to 28 days for each cohort
Secondary Outcome Measure Information:
Title
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
Description
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
Time Frame
3 months
Title
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
Description
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
Time Frame
3 months
Title
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
Description
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
Time Frame
3 months
Title
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
Description
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.
Time Frame
3 months
Title
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
Description
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.
Time Frame
3 months
Title
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
Description
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.
Time Frame
3 months
Title
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
Description
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
Time Frame
3 months
Title
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
Description
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
Time Frame
3 months
Title
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
Description
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
Time Frame
3 months
Title
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
Description
AUC(0-8h)
Time Frame
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Title
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
Title
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
Time Frame
1 day
Title
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
Description
AUC(0-8h)
Time Frame
Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose
Title
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
Title
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Fizazi
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Urology Center of Colorado
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Urology Health Team PLLC
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21327
Country
United States
Facility Name
Delaware Valley urology, LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Brooklyn Urology Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Klinika onkologie a radioterapie LFUK a FN
City
Hradec Králové
Country
Czech Republic
Facility Name
Fakultni Nemonicnice Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
City
Znojmo
Country
Czech Republic
Facility Name
East-Tallinn Central Hospital
City
Talinn
Country
Estonia
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Facility Name
Saint Louis Hospital
City
Paris
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24974051
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24974051
Description
PubMed link to the Lancet Oncology publication containing study results

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

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