NCT00636740

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merrion Pharmaceuticals, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-03-14
• Last updated: 2009-02-20

Locations

13 sites across 3 countries: United States, Estonia, Latvia