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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

NCT00636740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-02-20

No results posted yet for this study

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.

Conditions

  • Hormone-Refractory Prostate Cancer

Interventions

DRUG

Zoledronic Acid 20mg Tablets

Oral enteric coated tablets, 20mg, weekly, 8 weeks

DRUG

Zoledronic Acid

Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks

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

Sponsors & Collaborators

  • Merrion Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Thomas W Leonard, PhD · Merrion Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States
  • Estonia
  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636740 on ClinicalTrials.gov