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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00757757
Recruitment Status : Terminated
First Posted : September 23, 2008
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Bone Metastases Drug: MCS110 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MCS110 Drug: MCS110
Anti-M-CSF antibody

Primary Outcome Measures :
  1. Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase [ Time Frame: every cycle - (cycle = 28 days) ]
  2. Type and frequency of adverse drug reactions and serious adverse drug reactions [ Time Frame: every cycle - (cycle = 28 days) ]

Secondary Outcome Measures :
  1. Change in markers of bone resorption and formation (pre- vs. post-treatment) [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757757

United States, Nevada
NV Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00757757     History of Changes
Other Study ID Numbers: CMCS110A2101
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Prostate cancer
bone metastases
M-CSF antibody
Prostate Cancer with bone metastases

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases