Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
Sponsored by Merrion Pharmaceuticals, LLC
About this trial
Last updated 16 years ago
Study ID
MER-101-03
Status
Completed
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
18+ Years
Male
Not accepting
Healthy Volunteers
Trial Timing
Ended 16 years ago
What is this trial about?
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.
What are the participation requirements?
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)