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| Sponsored by: |
Merrion Pharmaceuticals, LLC |
|---|---|
| Information provided by: | Merrion Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT00636740 |
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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Estonia | |
| Tartu University Hospital | Recruiting |
| Tartu, Estonia | |
| Contact: Jaanus Kahu, MD 372-731-8044 | |
| Principal Investigator: Jaanus Kaku, MD | |
| North Estonian Regional Hospital | Recruiting |
| Tallinn, Estonia | |
| Contact: Leonhard Kukk, MD 372-617-1630 | |
| Principal Investigator: Leonhard Kukk, MD | |
| East Tallinn Central Hospital | Recruiting |
| Tallinn, Estonia | |
| Contact: Toomas Tamm, MD 372-620-7106 | |
| Principal Investigator: Toomas Tamm, MD | |
| Latvia | |
| O. Hublarovs Private Practice | Recruiting |
| Daugavpils, Latvia | |
| Contact: Olegs Hublarovs, MD 371-291-64333 | |
| Principal Investigator: Olegs Hublarovs, MD | |
| P. Stradina Clinical University Hospital | Recruiting |
| Riga, Latvia | |
| Contact: Egils Vjaters, MD 371-292-62596 | |
| Principal Investigator: Egils Vjaters, MD | |
| Study Director: | Thomas W Leonard, PhD | Merrion Pharmaceuticals, LLC |
More Information
| Responsible Party: | Merrion Pharmaceuticals, LLC ( Thomas W. Leonard, PhD ) |
| Study ID Numbers: | MER-101-03 |
| Study First Received: | March 7, 2008 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00636740 |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate cancer, hormone resistant, bisphosphonate |
|
Diphosphonates Zoledronic acid Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
|
Neoplasms Neoplasms by Site Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |
