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

This study is currently recruiting participants.

Verified by Novartis, April 2009

First Received: September 21, 2008 Last Updated: April 1, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00757757

Purpose

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

Condition	Intervention	Phase
Prostate Cancer Bone Metastases	Drug: MCS110	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase [ Time Frame: every cycle - (cycle = 28 days) ] [ Designated as safety issue: Yes ]
Type and frequency of adverse drug reactions and serious adverse drug reactions [ Time Frame: every cycle - (cycle = 28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in markers of bone resorption and formation (pre- vs. post-treatment) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MCS110 Anti-M-CSF antibody

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757757

Contacts

Contact: Novartis Pharmaceuticals

+1-800-340-6843

Locations

United States, Nevada
NV Cancer Institute	Not yet recruiting
Las Vegas, Nevada, United States, 89135
Contact: Nicholas Vogelzang, M.D. 702-822-5433 nvogelzang@nvcancer.org
Principal Investigator: Nicholas Vogelzang, M.D.
United States, Texas
CTRC	Recruiting
San Antonio, Texas, United States, 78229
Contact: John Sarantopoulas, M.D. 210-450-1789 sarantopoulo@uthscsa.edu
Principal Investigator: John Sarantopoulas, M.D.

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CMCS110A2101
Study First Received:	September 21, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00757757 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Prostate cancer
bone metastases
anti-M-CSF

M-CSF antibody
M-CSF
Prostate Cancer with bone metastases

Study placed in the following topic categories:

Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Hematologic Diseases
Urogenital Neoplasms
Genital Diseases, Male
Bone Diseases

Antibodies
Musculoskeletal Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Prostatic Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Hematologic Diseases
Urogenital Neoplasms
Genital Diseases, Male
Bone Diseases
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Musculoskeletal Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009