Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

Phase 2

Completed

• Conditions: Hormone-Refractory Prostate Cancer
• Interventions: Drug: Zoledronic Acid 20mg Tablets; Drug: Zoledronic Acid

• Registration Number: NCT00636740
• Lead Sponsor: Merrion Pharmaceuticals, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-14
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-19
• Last Update Posted: 2009-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Zoledronic Acid 20mg Tablets	MER-101 20mg Tablets Regimen 1
C	Zoledronic Acid 20mg Tablets	MER-101 20mg Tablets Regimen 2
A	Zoledronic Acid	Zometa Injection

Primary Outcome Measures

Name	Time	Method
Effects on 4 markers of bone metabolism	Weekly

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory	Monthly

Trial Locations

Locations (13)

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

New York Urological Associates, PC; 🇺🇸 New York, New York, United States

Green Clinic, LLC; 🇺🇸 Ruston, Louisiana, United States

Charleston Hematology Oncology Associates, PA; 🇺🇸 Charleston, South Carolina, United States

North Estonian Regional Hospital; 🇪🇪 Tallinn, Estonia

P. Stradina Clinical University Hospital; 🇱🇻 Riga, Latvia

Innovative Medical Research of South Florida, Inc.; 🇺🇸 Miami, Florida, United States

Cancer Outreach Associates, P.C.; 🇺🇸 Abingdon, Virginia, United States

Tartu University Hospital; 🇪🇪 Tartu, Estonia

O. Hublarovs Private Practice; 🇱🇻 Daugavpils, Latvia

East Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia