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

NCT ID: NCT00757757

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer Bone Metastases

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MCS110

Group Type EXPERIMENTAL

MCS110

Intervention Type DRUG

Anti-M-CSF antibody

Interventions

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MCS110

Anti-M-CSF antibody

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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NV Cancer Institute

Las Vegas, Nevada, United States

Site Status

CTRC

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4613

Results for CMCS110A2101 from the Novartis Clinical Trials website

Other Identifiers

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CMCS110A2101

Identifier Type: -

Identifier Source: org_study_id