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

Hormone-Refractory Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636740
• Other study ID #: MER-101-03
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2008
• Last updated: February 19, 2009
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Merrion Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone-Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, weekly, 8 weeks
• Zoledronic Acid
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merrion Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  Estonia,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on 4 markers of bone metabolism		Weekly	No
Secondary	Brief Pain Inventory		Monthly	No