Metastatic Bone Disease (MBD) MedDRA version: 8.1 Level: LLT Classification code 10027452 Term: Metastases to bone
Conditions
Interventions
Product Name: MK-0822 () Chemical name: N1-(1-cyanocyclopropyl)-4-fluoro-N2-{(1S)-2,2,2-trifluoro-1-[4’-(methylsul
Product Code: MK-0822
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo:
Sponsors
Merck & Co Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women with breast cancer and MBD • Postmenopausal or using adequate contraception • Stable chemotherapy or hormone therapy regimen • Recovered from radiotherapy or surgery • Urinary NTx > 50 nmol BCE/mmol creatinine • Performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Current bisphosphonate use or bisphosphonate use within the prior 3 m months • Investigational drugs within the prioir 4 weeks • CNS metastases or meningeal involvement or primary CNS tumor • Ascites or pleural effusion with significant symptoms • Other primary cancer • Other significant, concurrent disease • Psychiatric disorders or substance abuse • Breast feeding or expected to conceive Patient has significant hypercalcemia (defined as serum calcium >2.7 mmol/L or >10.8 mg/dL). Patient is known to be HIV positive or has an AIDS-related illness or has a known history of active hepatitis B or C. Patient had a prior malignancy with the exceptions of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; or has undergone potentially curative therapy with no evidence of recurrence for 5 years and is deemed at low risk for recurrence by the treating physician. The patient has a known clinical hypersensitivity to zoledronic acid, or other bisphosphonates. The patient plans to undergo invasive dental procedures, such as dental surgery or tooth extraction, during the 6 weeks of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: E.2.1 Main objective: To assess the safety, tolerability, and biochemical efficacy (changes in urinary NTx) of MK-0822 in women with breast cancer and MBD;Secondary Objective: E.2.2 Secondary objectives: To assess the efficacy of MK-0822 on additional biochemical parameters and its pharmakokinetic properties;Primary end point(s): • Urinary NTx • Safety and tolerability | — |
Countries
Germany, Italy, Norway
Outcome results
None listed