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

Tracking Information

First Received Date ^ICMJE

September 21, 2008

Last Updated Date

November 10, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase [ Time Frame: every cycle - (cycle = 28 days) ] [ Designated as safety issue: Yes ]
Type and frequency of adverse drug reactions and serious adverse drug reactions [ Time Frame: every cycle - (cycle = 28 days) ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
Type and frequency of adverse drug reactions and serious adverse drug reactions

Change History

Complete list of historical versions of study NCT00757757 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in markers of bone resorption and formation (pre- vs. post-treatment) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer
Bone Metastases

Intervention ^ICMJE

Drug: MCS110

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00757757

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CMCS110A2101

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP