Hormone - refractory prostate cancer with bone metastases and no prior bisphoshonate treatment MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Product Name: MER-101 20mg
Product Code: MER-101 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Zoledronic acid
CAS Number: 165800066
Current Sponsor code: MER-101
Other descriptive name: ZOLED
Sponsors
Merrion Pharmaceuticals plc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: To obtain plasma pharmacokinetic profiles of MER-101 tablets and Zometa 4 mg injection in a limited number of patients (n=8) on Day 28 (48 hours).;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. | — |
Countries
Estonia, Latvia
Outcome results
None listed