Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Information source: Merrion Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hormone-Refractory Prostate Cancer
Intervention: Zoledronic Acid 20mg Tablets (Drug); Zoledronic Acid (Drug); Zoledronic Acid 20mg Tablets (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merrion Pharmaceuticals, LLC Official(s) and/or principal investigator(s): Thomas W Leonard, PhD, Study Director, Affiliation: Merrion Pharmaceuticals, LLC
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effects on 4 markers of bone metabolism
Secondary outcome: Brief Pain Inventory
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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)
Locations and Contacts
East Tallinn Central Hospital, Tallinn, Estonia
North Estonian Regional Hospital, Tallinn, Estonia
Tartu University Hospital, Tartu, Estonia
O. Hublarovs Private Practice, Daugavpils, Latvia
P. Stradina Clinical University Hospital, Riga, Latvia
Birmingham Hematology & Oncology Associates, LLC, Birmingham, Alabama 35223, United States
Cancer Care of North Florida, P.A., Lake City, Florida 32055, United States
Lakeland Regional Cancer Center, Lakeland, Florida 33805, United States
Innovative Medical Research of South Florida, Inc., Miami, Florida 33179, United States
Green Clinic, LLC, Ruston, Louisiana 71270, United States
New York Urological Associates, PC, New York, New York 10022, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina 29403, United States
Cancer Outreach Associates, P.C., Abingdon, Virginia 24211, United States
Additional Information
Starting date: February 2008
Last updated: February 19, 2009
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