Back to resultsMulti-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Primary Purpose
Hormone-Refractory Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zoledronic Acid 20mg Tablets
Zoledronic Acid
Zoledronic Acid 20mg Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Hormone-Refractory Prostate Cancer focused on measuring Prostate cancer, hormone resistant, bisphosphonate
Eligibility Criteria
Inclusion Criteria:
- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
Exclusion Criteria:
- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Sites / Locations
- Birmingham Hematology & Oncology Associates, LLC
- Cancer Care of North Florida, P.A.
- Lakeland Regional Cancer Center
- Innovative Medical Research of South Florida, Inc.
- Green Clinic, LLC
- New York Urological Associates, PC
- Charleston Hematology Oncology Associates, PA
- Cancer Outreach Associates, P.C.
- East Tallinn Central Hospital
- North Estonian Regional Hospital
- Tartu University Hospital
- O. Hublarovs Private Practice
- P. Stradina Clinical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
B
C
A
Arm Description
MER-101 20mg Tablets Regimen 1
MER-101 20mg Tablets Regimen 2
Zometa Injection
Outcomes
Primary Outcome Measures
Effects on 4 markers of bone metabolism
Secondary Outcome Measures
Brief Pain Inventory
Full Information
NCT ID
NCT00636740
First Posted
March 7, 2008
Last Updated
February 19, 2009
Sponsor
Merrion Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00636740
Brief Title
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Official Title
A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merrion Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone-Refractory Prostate Cancer
Keywords
Prostate cancer, hormone resistant, bisphosphonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Experimental
Arm Description
MER-101 20mg Tablets Regimen 1
Arm Title
C
Arm Type
Experimental
Arm Description
MER-101 20mg Tablets Regimen 2
Arm Title
A
Arm Type
Active Comparator
Arm Description
Zometa Injection
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid 20mg Tablets
Other Intervention Name(s)
MER-101
Intervention Description
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Other Intervention Name(s)
Zometa
Intervention Description
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid 20mg Tablets
Other Intervention Name(s)
MER-101
Intervention Description
Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
Primary Outcome Measure Information:
Title
Effects on 4 markers of bone metabolism
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Time Frame
Monthly
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
Exclusion Criteria:
Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W Leonard, PhD
Organizational Affiliation
Merrion Pharmaceuticals, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology & Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35223
Country
United States
Facility Name
Cancer Care of North Florida, P.A.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Green Clinic, LLC
City
Ruston
State/Province
Louisiana
ZIP/Postal Code
71270
Country
United States
Facility Name
New York Urological Associates, PC
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Charleston Hematology Oncology Associates, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Cancer Outreach Associates, P.C.
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
East Tallinn Central Hospital
City
Tallinn
Country
Estonia
Facility Name
North Estonian Regional Hospital
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Facility Name
O. Hublarovs Private Practice
City
Daugavpils
Country
Latvia
Facility Name
P. Stradina Clinical University Hospital
City
Riga
Country
Latvia
12. IPD Sharing Statement
Learn more about this trial
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
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