A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD) - Women with Breast Cancer and Established Metastatic Bone Disease
- Conditions
- Metastatic Bone Disease (MBD)MedDRA version: 8.1Level: LLTClassification code 10027452Term: Metastases to bone
- Registration Number
- EUCTR2006-002669-38-DE
- Lead Sponsor
- Merck & Co Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 45
•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 < 2.0 on the ECOG Performance Scale
•Adequate organ function
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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>•Safety and tolerability<br>
- Secondary Outcome Measures
Name Time Method