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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

Sponsor
Merrion Pharmaceuticals, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00636740
Collaborator
(none)
30
Enrollment
13
Locations
3
Arms
12
Duration (Months)
2.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Zoledronic Acid 20mg Tablets
  • Drug: Zoledronic Acid
  • Drug: Zoledronic Acid 20mg Tablets
 Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

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

    		•
    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 Names:
  • MER-101

    		•
    Active Comparator: A

    Zometa Injection

    Drug: Zoledronic Acid
    Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
    Other Names:
  • Zometa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effects on 4 markers of bone metabolism [Weekly]

    Secondary Outcome Measures

    1. Brief Pain Inventory [Monthly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Hematology & Oncology Associates, LLC Birmingham Alabama United States 35223
    2 Cancer Care of North Florida, P.A. Lake City Florida United States 32055
    3 Lakeland Regional Cancer Center Lakeland Florida United States 33805
    4 Innovative Medical Research of South Florida, Inc. Miami Florida United States 33179
    5 Green Clinic, LLC Ruston Louisiana United States 71270
    6 New York Urological Associates, PC New York New York United States 10022
    7 Charleston Hematology Oncology Associates, PA Charleston South Carolina United States 29403
    8 Cancer Outreach Associates, P.C. Abingdon Virginia United States 24211
    9 East Tallinn Central Hospital Tallinn Estonia
    10 North Estonian Regional Hospital Tallinn Estonia
    11 Tartu University Hospital Tartu Estonia
    12 O. Hublarovs Private Practice Daugavpils Latvia
    13 P. Stradina Clinical University Hospital Riga Latvia

    Sponsors and Collaborators

    • Merrion Pharmaceuticals, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00636740
    Other Study ID Numbers:
    • MER-101-03
    First Posted:
    Mar 14, 2008
    Last Update Posted:
    Feb 20, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    Prostate cancer, hormone resistant, bisphosphonate
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Zoledronic Acid

    Study Results

    No Results Posted as of Feb 20, 2009