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

February 19, 2009 updated by: Merrion Pharmaceuticals, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • MER-101
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 Names:
  • MER-101
Experimental: C
MER-101 20mg Tablets Regimen 2
Drug: Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Other Names:
  • MER-101
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 Names:
  • MER-101
Active Comparator: A
Zometa Injection
Drug: Zoledronic Acid
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Other Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects on 4 markers of bone metabolism
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Brief Pain Inventory
Time Frame: Monthly
Monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrion Pharmaceuticals, LLC

Investigators

  • Study Director: Thomas W Leonard, PhD, Merrion Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MER-101-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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