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NCT00757757 Clinical Trial

A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases

Prostate Cancer Clinical Trial

Official title:
A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00757757
Other study ID # CMCS110A2101
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2008
Est. completion date August 2009

Study information
Verified date August 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MCS110
Anti-M-CSF antibody

Locations
Country Name City State
United States NV Cancer Institute Las Vegas Nevada
United States CTRC San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase every cycle - (cycle = 28 days)
Primary Type and frequency of adverse drug reactions and serious adverse drug reactions every cycle - (cycle = 28 days)
Secondary Change in markers of bone resorption and formation (pre- vs. post-treatment) 3 months
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