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

This study has been completed.
Sponsor:
Information provided by:
Merrion Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00636740
First received: March 7, 2008
Last updated: February 19, 2009
Last verified: February 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Estonia
East Tallinn Central Hospital
Tallinn, Estonia
North Estonian Regional Hospital
Tallinn, Estonia
Tartu University Hospital
Tartu, 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: Thomas W. Leonard, PhD, Merrion Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00636740     History of Changes
Other Study ID Numbers: MER-101-03
Study First Received: March 7, 2008
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrion Pharmaceuticals, LLC:
Prostate cancer, hormone resistant, bisphosphonate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Hormones
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014