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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Hormone-Refractory Prostate Cancer
Interventions
DRUG

Zoledronic Acid 20mg Tablets

Oral enteric coated tablets, 20mg, weekly, 8 weeks

DRUG

Zoledronic Acid

Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks

DRUG

Zoledronic Acid 20mg Tablets

Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8

Trial Locations (13)

10022

New York Urological Associates, PC, New York

24211

Cancer Outreach Associates, P.C., Abingdon

29403

Charleston Hematology Oncology Associates, PA, Charleston

32055

Cancer Care of North Florida, P.A., Lake City

33179

Innovative Medical Research of South Florida, Inc., Miami

33805

Lakeland Regional Cancer Center, Lakeland

35223

Birmingham Hematology & Oncology Associates, LLC, Birmingham

71270

Green Clinic, LLC, Ruston

Unknown

East Tallinn Central Hospital, Tallinn

North Estonian Regional Hospital, Tallinn

Tartu University Hospital, Tartu

O. Hublarovs Private Practice, Daugavpils

P. Stradina Clinical University Hospital, Riga

Sponsors
All Listed Sponsors
lead

Merrion Pharmaceuticals, LLC

INDUSTRY