Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
This study has been completed.
Sponsor:
Merrion Pharmaceuticals, LLC
Information provided by:
Merrion Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00636740
First received: March 7, 2008
Last updated: February 19, 2009
Last verified: February 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 ]
| Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B
MER-101 20mg Tablets Regimen 1
|
Drug: Zoledronic Acid 20mg Tablets
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Other Name: MER-101
|
|
Experimental: C
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
Other Name: MER-101
|
|
Active Comparator: A
Zometa Injection
|
Drug: Zoledronic Acid
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Other Name: Zometa
|
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 | |
| Birmingham, Alabama, United States, 35223 | |
| United States, Florida | |
| Cancer Care of North Florida, P.A. | |
| Lake City, Florida, United States, 32055 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33805 | |
| Innovative Medical Research of South Florida, Inc. | |
| Miami, Florida, United States, 33179 | |
| United States, Louisiana | |
| Green Clinic, LLC | |
| Ruston, Louisiana, United States, 71270 | |
| United States, New York | |
| New York Urological Associates, PC | |
| New York, New York, United States, 10022 | |
| United States, South Carolina | |
| Charleston Hematology Oncology Associates, PA | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Virginia | |
| Cancer Outreach Associates, P.C. | |
| Abingdon, Virginia, United States, 24211 | |
| Estonia | |
| East Tallinn Central Hospital | |
| Tallinn, Estonia | |
| North Estonian Regional Hospital | |
| Tallinn, Estonia | |
| Tartu University Hospital | |
| Tartu, Estonia | |
| Latvia | |
| O. Hublarovs Private Practice | |
| Daugavpils, Latvia | |
| P. Stradina Clinical University Hospital | |
| Riga, Latvia | |
Sponsors and Collaborators
Merrion Pharmaceuticals, LLC
Investigators
| Study Director: | Thomas W Leonard, PhD | Merrion Pharmaceuticals, LLC |
More Information
No publications provided
| Responsible Party: | Thomas W. Leonard, PhD, Merrion Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT00636740 History of Changes |
| Other Study ID Numbers: | MER-101-03 |
| Study First Received: | March 7, 2008 |
| Last Updated: | February 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merrion Pharmaceuticals, LLC:
|
Prostate cancer, hormone resistant, bisphosphonate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Zoledronic acid Diphosphonates Hormones Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013