A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
- Registration Number
- NCT00757757
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 3
Inclusion Criteria
- Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
- 18 years old and over
Exclusion Criteria
- Plan to be on cytotoxic or biologic therapy during study
- Active dental problems
- Active heart complications
- Active infection
- Patients with moderate to severe swelling due to fluid
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MCS110 MCS110 -
- Primary Outcome Measures
Name Time Method Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase every cycle - (cycle = 28 days) Type and frequency of adverse drug reactions and serious adverse drug reactions every cycle - (cycle = 28 days)
- Secondary Outcome Measures
Name Time Method Change in markers of bone resorption and formation (pre- vs. post-treatment) 3 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does MCS110 utilize to target prostate cancer bone metastases?
How does MCS110 compare to standard-of-care treatments for castration-resistant prostate cancer with bone metastases?
What biomarkers are associated with response to MCS110 in patients with prostate cancer bone metastases?
What are the potential adverse events and management strategies for MCS110 in prostate cancer patients?
Are there combination therapies involving MCS110 and other agents for treating prostate cancer bone metastases?
Trial Locations
- Locations (2)
NV Cancer Institute
🇺🇸Las Vegas, Nevada, United States
CTRC
🇺🇸San Antonio, Texas, United States
NV Cancer Institute🇺🇸Las Vegas, Nevada, United States