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

Primary Purpose

Prostate Cancer, Bone Metastases

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MCS110
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, bone metastases, anti-M-CSF, M-CSF antibody, M-CSF, Prostate Cancer with bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • NV Cancer Institute
  • CTRC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MCS110

Arm Description

Outcomes

Primary Outcome Measures

Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
Type and frequency of adverse drug reactions and serious adverse drug reactions

Secondary Outcome Measures

Change in markers of bone resorption and formation (pre- vs. post-treatment)

Full Information

First Posted
September 21, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00757757
Brief Title
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Bone Metastases
Keywords
Prostate cancer, bone metastases, anti-M-CSF, M-CSF antibody, M-CSF, Prostate Cancer with bone metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCS110
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MCS110
Intervention Description
Anti-M-CSF antibody
Primary Outcome Measure Information:
Title
Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
Time Frame
every cycle - (cycle = 28 days)
Title
Type and frequency of adverse drug reactions and serious adverse drug reactions
Time Frame
every cycle - (cycle = 28 days)
Secondary Outcome Measure Information:
Title
Change in markers of bone resorption and formation (pre- vs. post-treatment)
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NV Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
CTRC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4613
Description
Results for CMCS110A2101 from the Novartis Clinical Trials website

Learn more about this trial

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

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