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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

Page last updated: August 23, 2015

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