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

Phase 1

Terminated

• Conditions: Prostate Cancer; Bone Metastases
• Interventions: Drug: MCS110

• Registration Number: NCT00757757
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-21
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Disposition First Submitted: 2013-02-09
• Disposition First Submitted QC: 2013-02-09
• Disposition First Posted: 2013-02-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCS110	MCS110	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

CTRC; 🇺🇸 San Antonio, Texas, United States

NV Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States