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

Sponsor:	Merrion Pharmaceuticals, LLC
Information provided by:	Merrion Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00636740

Purpose

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.

Condition	Intervention	Phase
Hormone-Refractory Prostate Cancer	Drug: Zoledronic Acid 20mg Tablets Drug: Zoledronic Acid Drug: Zoledronic Acid 20mg Tablets	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Merrion Pharmaceuticals, LLC:

Primary Outcome Measures:

Effects on 4 markers of bone metabolism [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brief Pain Inventory [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	February 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental MER-101 20mg Tablets Regimen 1	Drug: Zoledronic Acid 20mg Tablets Oral enteric coated tablets, 20mg, weekly, 8 weeks
C: Experimental MER-101 20mg Tablets Regimen 2	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
A: Active Comparator Zometa Injection	Drug: Zoledronic Acid Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636740

Locations

United States, Alabama
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, United States, 35223
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Cancer Care of North Florida, P.A.
Lake City, Florida, United States, 32055
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States, 33179
United States, Louisiana
Green Clinic, LLC
Ruston, Louisiana, United States, 71270
United States, New York
New York Urological Associates, PC
New York, New York, United States, 10022
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29403
United States, Virginia
Cancer Outreach Associates, P.C.
Abingdon, Virginia, United States, 24211
Estonia
Tartu University Hospital
Tartu, Estonia
North Estonian Regional Hospital
Tallinn, Estonia
East Tallinn Central Hospital
Tallinn, Estonia
Latvia
O. Hublarovs Private Practice
Daugavpils, Latvia
P. Stradina Clinical University Hospital
Riga, Latvia

Sponsors and Collaborators

Merrion Pharmaceuticals, LLC

Investigators

Study Director:

Thomas W Leonard, PhD

Merrion Pharmaceuticals, LLC

More Information

No publications provided

Responsible Party:	Merrion Pharmaceuticals, LLC ( Thomas W. Leonard, PhD )
Study ID Numbers:	MER-101-03
Study First Received:	March 7, 2008
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00636740 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merrion Pharmaceuticals, LLC:

Prostate cancer, hormone resistant, bisphosphonate

Additional relevant MeSH terms:

Zoledronic acid
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bone Density Conservation Agents

Genital Diseases, Male
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Diphosphonates
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009