Hormone-Refractory Prostate CancerPhase 2NCT00636740
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 Phase 2 study testing Zoledronic Acid 20mg Tablets and Zoledronic Acid in people with Hormone-Refractory Prostate Cancer, run by Merrion Pharmaceuticals, LLC at 13 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-Refractory Prostate Cancer
- What is being tested?
- Zoledronic Acid 20mg Tablets and Zoledronic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Feb 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
Who cannot join
- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States8 sites
Cancer Outreach Associates, P.C.
Abingdon, Virginia, 24211
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, 35223
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29403
Cancer Care of North Florida, P.A.
Lake City, Florida, 32055
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Innovative Medical Research of South Florida, Inc.
Miami, Florida, 33179
New York Urological Associates, PC
New York, New York, 10022
Green Clinic, LLC
Ruston, Louisiana, 71270
Estonia3 sites
East Tallinn Central Hospital
Tallinn
North Estonian Regional Hospital
Tallinn
Tartu University Hospital
Tartu
Latvia2 sites
O. Hublarovs Private Practice
Daugavpils
P. Stradina Clinical University Hospital
Riga
About this 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
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
- Being tested
- Zoledronic Acid 20mg Tablets, Zoledronic Acid
- Keywords
- Prostate cancer, hormone resistant, bisphosphonate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid 20mg TabletsDrug
Also called MER-101
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Zoledronic AcidDrug
Also called Zometa
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Zoledronic Acid 20mg TabletsDrug
Also called MER-101
Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | MER-101 20mg Tablets Regimen 1 Receives: Drug: Zoledronic Acid 20mg Tablets |
| C | Experimental | MER-101 20mg Tablets Regimen 2 Receives: Drug: Zoledronic Acid 20mg Tablets |
| A | Active comparator | Zometa Injection Receives: Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on 4 markers of bone metabolism
Measured: Weekly
Secondary outcomes (1)
Brief Pain Inventory
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-Refractory Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrion Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas W Leonard, PhD, Study director, Merrion Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636740
- Sponsor's protocol ID
- MER-101-03
- Status last verified
- Feb 2009
- First submitted
- 7 Mar 2008
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00636740
- Acronym / sponsor ID
- MER-101-03
- Conditions
- Hormone-Refractory Prostate Cancer
- Keywords
- Prostate cancer, hormone resistant, bisphosphonate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merrion Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Zoledronic Acid 20mg TabletsMER-101 20mg Tablets Regimen 1 |
| C | Experimental | Drug: Zoledronic Acid 20mg TabletsMER-101 20mg Tablets Regimen 2 |
| A | Active comparator | Drug: Zoledronic AcidZometa Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.
Key exclusion criteria (1 listed)
- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid 20mg TabletsAlso: MER-101Oral enteric coated tablets, 20mg, weekly, 8 weeks | Drug | B |
| Zoledronic AcidAlso: ZometaZoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks | Drug | A |
| Zoledronic Acid 20mg TabletsAlso: MER-101Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8 | Drug | C |
Primary outcome
Effects on 4 markers of bone metabolism
Time frame: Weekly
1 secondary outcome
Brief Pain Inventory
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas W Leonard, PhD study director
Merrion Pharmaceuticals, LLC
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic Acid 20mg Tablets and Zoledronic Acid in people with Hormone-Refractory Prostate Cancer, run by Merrion Pharmaceuticals, LLC at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Estonia, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on 4 markers of bone metabolism (time frame: Weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.