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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636740
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : February 20, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hormone-Refractory Prostate Cancer Drug: Zoledronic Acid 20mg Tablets Drug: Zoledronic Acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: B
MER-101 20mg Tablets Regimen 1
Drug: Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Other Name: MER-101

Experimental: C
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
Other Name: MER-101

Active Comparator: A
Zometa Injection
Drug: Zoledronic Acid
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Other Name: Zometa

Primary Outcome Measures :
  1. Effects on 4 markers of bone metabolism [ Time Frame: Weekly ]

Secondary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: Monthly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00636740

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United States, Alabama
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, United States, 35223
United States, Florida
Cancer Care of North Florida, P.A.
Lake City, Florida, United States, 32055
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
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
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
Sponsors and Collaborators
Merrion Pharmaceuticals, LLC
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Study Director: Thomas W Leonard, PhD Merrion Pharmaceuticals, LLC

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Responsible Party: Thomas W. Leonard, PhD, Merrion Pharmaceuticals, LLC Identifier: NCT00636740     History of Changes
Other Study ID Numbers: MER-101-03
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009
Keywords provided by Merrion Pharmaceuticals, LLC:
Prostate cancer, hormone resistant, bisphosphonate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents