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 metasteases (MBD) - mk 0822 pn 016
- Conditions
- treatment of women with breat cancer and mbdMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer
- Registration Number
- EUCTR2006-002669-38-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 45
2.2 SUBJECT/PATIENT INCLUSION CRITERIA
1) Patient has histologically- and/or cytologically-confirmed breast cancer.
2) Patient has documented skeletal metastases. Historical bone scans taken up to
12 months prior to study start are acceptable.
3) Patient is a woman >= 18 years of age on day of signing the informed consent.
4) Patient is not receiving chemotherapy OR if patient is receiving chemotherapy,
she is on a stable chemotherapy regimen for at least 1 month at the time of
screening (Visit 1).
5) Patient is not receiving hormonal therapy OR if patient is receiving hormonal
therapy, she is on a stable regimen for at least 3 months at the time of screening
(Visit 1).
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
Patients meeting any of the following criteria are not eligible to participate in this study:
1) Patient is undergoing current oral bisphosphonate therapy OR has history of oral or
IV bisphosphonate use within 3 months of screening (Visit 1).
2) Patient has a presence of clinically apparent central nervous system (CNS)
metastases or carcinomatous meningitis. A patient with CNS metastases who has
completed a course of radiotherapy prior to screening (Visit 1), and is clinically
stable in the judgment of the investigator is eligible.
3) Patient has a primary CNS tumor.
4) Patient has presence of ascites or pleural effusion causing significant symptoms.
5) Patient is currently participating or has participated in a study with an investigational
compound or device within 30 days of signing the informed consent.
6) Patient has active and uncontrolled infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method