A multi-center Phase II study to compare MER-101 20mg tablets to intravenous Zometa® 4mg in male bisphosphonate-naïve, hormone-refractory prostate cancer patients
- Conditions
- Hormone - refractory prostate cancer with bone metastases and no prior bisphoshonate treatmentMedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer
- Registration Number
- EUCTR2008-001395-74-LV
- Lead Sponsor
- Merrion Pharmaceuticals plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 30
1/. Ability to provide informed consent.
2/. Hormone refractory status as evidenced by history of rising PSA levels - last 2 of 3 PSA levels must be above nadir.
3/. No prior bisphosphonate treatment.
4/. Radiographically-confirmed bone metastases.
5/. 18 years of age or older.
6/. ECOG of 2 or less within the last 30 days prior to randomization (Appendix I).
7/. Adequate organ function defined as:
•Creatinine clearance of = 60mL/min (as calculated from serum creatinine via the Cockraft-Gault formula).
•Albumin-adjusted serum calcium =8.0 mg/dL and =11.5 mg/dL.
8/. No reported dental problems within 6 months of randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1/. Active dental or jaw condition that requires dental surgery.
2/. History of osteonecrosis / osteomyelitis of the jaw or delayed healing after dental surgery.
3/. Planned dental surgery within 3 months.
4/. Planned surgery or radiation to bone within 3 months.
5/. AST/ALT >3x the ULN.
6/. Known allergy or hypersensitivity to zoledronic acid.
7/. History of alcohol or other substance abuse within the year immediately prior to anticipated study entry.
8/. Use of an investigational drug in the past 30 days prior to randomization.
9/. Life expectancy < 6 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase II study to examine the pharmacodynamic effects on biomarkers of two different regimens of MER-101 20mg tablets versus Zometa® 4mg IV infusion once-monthly therapy in male bisphosphonate-naïve hormone-refractory prostate cancer patients.;Secondary Objective: none;Primary end point(s): The primary efficacy assessments include response of bioequivalence of 4 biomarkers (Urine NTX; Serum CTX; Serum bone specific alkaline phosphatase; and Serum Calcium), which will be evaluated on Days -7, 0, 7, 14, 21, 28, 35, 42, 49 and 56.<br><br><br><br>
- Secondary Outcome Measures
Name Time Method