Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Completed · Phase 2
Conditions studied: Hormone-Refractory Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00636740
- Run by
- Merrion Pharmaceuticals, LLC
- People needed
- 30
- Starts
- 2008-02-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2009-02-20
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
You may not qualify if…
- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Where it is running
- Birmingham Hematology & Oncology Associates, LLC — Birmingham, Alabama, United States
- Cancer Care of North Florida, P.A. — Lake City, Florida, United States
- Lakeland Regional Cancer Center — Lakeland, Florida, United States
- Innovative Medical Research of South Florida, Inc. — Miami, Florida, United States
- Green Clinic, LLC — Ruston, Louisiana, United States
- New York Urological Associates, PC — New York, New York, United States
- Charleston Hematology Oncology Associates, PA — Charleston, South Carolina, United States
- Cancer Outreach Associates, P.C. — Abingdon, Virginia, United States
- 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
Full record on ClinicalTrials.gov
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