A Phase I/II Open-label Study of MCS110 in Patients With... | NCT00757757

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

NCT00757757

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Dec 19, 2020Actual

Enrollment

3Actual

Phase

Phase 1Phase 2

Conditions

Prostate Cancer
Bone Metastases

Interventions

MCS110

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Sep 21, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 9, 2013

Certification/Extension First Submitted that Passed QC Review

Feb 9, 2013

Certification/Extension First Posted Date

Feb 12, 2013Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MCS110	Experimental		Drug: MCS110

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MCS110	Drug	Anti-M-CSF antibody	MCS110

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in markers of bone resorption and formation (pre- vs. post-treatment)		3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NV Cancer Institute		Las Vegas	Nevada	89135	United States
CTRC

References Module

Citations

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms