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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757757

Enrollment

Registered

2008-09-23

Start date

2008-09-30

Completion date

2009-08-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Bone Metastases

Keywords

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

Brief summary

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

Interventions

DRUGMCS110

Anti-M-CSF antibody

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026