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 - Full Text View

Purpose

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	Intervention	Phase
Hormone-Refractory Prostate Cancer	Drug: Zoledronic Acid 20mg Tablets Drug: Zoledronic Acid Drug: Zoledronic Acid 20mg Tablets	Phase II

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Merrion Pharmaceuticals, LLC:

Primary Outcome Measures:

Effects on 4 markers of bone metabolism [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brief Pain Inventory [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental MER-101 20mg Tablets Regimen 1	Drug: Zoledronic Acid 20mg Tablets Oral enteric coated tablets, 20mg, weekly, 8 weeks
C: Experimental 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
A: Active Comparator Zometa Injection	Drug: Zoledronic Acid Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636740

Locations


United States, Alabama
	Birmingham Hematology & Oncology Associates, LLC	Recruiting
	Birmingham, Alabama, United States, 35223
	Contact: Jimmie Harvey, MD 205-592-5077
	Contact: Kevin Windsor, MD 205-592-5077
	Principal Investigator: Jimmie Harvey, MD

United States, Florida
	Lakeland Regional Cancer Center	Recruiting
	Lakeland, Florida, United States, 33805
	Contact: G. Byron Hodge, Jr., MD 863-904-1900
	Contact: Robert H. Cassell, MD, PhD 863-904-1900
	Principal Investigator: G. Byron Hodge, Jr., MD
	Cancer Care of North Florida, P.A.	Recruiting
	Lake City, Florida, United States, 32055
	Contact: Waseem Khan, MD 386-755-1655
	Contact: Sheila Roberts, ARNP 386-755-1655
	Principal Investigator: Waseem Khan, MD
	Innovative Medical Research of South Florida, Inc.	Recruiting
	Miami, Florida, United States, 33179
	Contact: Marc A. Saltzman, MD 305-759-1881
	Contact: Bojana B Bhardwaj, MD 305-759-1881
	Principal Investigator: Marc A. Saltzman, MD

United States, Louisiana
	Green Clinic, LLC	Recruiting
	Ruston, Louisiana, United States, 71270
	Contact: David C. Osafo, MD 318-251-6352
	Principal Investigator: David C. Osafo, MD

United States, New York
	New York Urological Associates, PC	Recruiting
	New York, New York, United States, 10022
	Contact: John A Fracchia, MD 212-570-6800
	Contact: Noel A Armenakas, MD 212-570-6800
	Principal Investigator: John A Fracchia, MD

United States, South Carolina
	Charleston Hematology Oncology Associates, PA	Recruiting
	Charleston, South Carolina, United States, 29403
	Contact: George F Geils Jr, MD 843-577-6957
	Contact: David M Ellison, MD 843-577-6957
	Principal Investigator: George F Geils Jr, MD

United States, Virginia
	Cancer Outreach Associates, P.C.	Recruiting
	Abingdon, Virginia, United States, 24211
	Contact: Maureen Ross, MD 276-676-1860
	Contact: Thomas Johnson, MD 276-676-1860
	Principal Investigator: Maureen Ross, MD

Sponsors and Collaborators

Merrion Pharmaceuticals, LLC

More Information

Responsible Party:	Merrion Pharmaceuticals, LLC ( Thomas W. Leonard, PhD )
Study ID Numbers:	MER-101-03
First Received:	March 7, 2008
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00636740
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merrion Pharmaceuticals, LLC:

Prostate cancer, hormone resistant, bisphosphonate

Study placed in the following topic categories:

Diphosphonates

Zoledronic acid

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Merrion Pharmaceuticals, LLC
Information provided by:	Merrion Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00636740