NCT00757757

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 19, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

September 21, 2008

Last Update Submit

December 11, 2020

Conditions

Prostate CancerBone Metastases

Keywords

Prostate cancerbone metastasesanti-M-CSFM-CSF antibodyM-CSFProstate Cancer with bone metastases

Outcome Measures

Primary Outcomes (2)

  • Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase

    every cycle - (cycle = 28 days)

  • Type and frequency of adverse drug reactions and serious adverse drug reactions

    every cycle - (cycle = 28 days)

Secondary Outcomes (1)

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

    3 months

Study Arms (1)

MCS110

EXPERIMENTAL
Drug: MCS110

Interventions

MCS110DRUG

Anti-M-CSF antibody

MCS110

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
  • years old and over

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NV Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

CTRC

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 19, 2020

Record last verified: 2020-08

Locations

US(2)