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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00757757
First received: September 21, 2008
Last updated: February 9, 2013
Last verified: February 2013

September 21, 2008
February 9, 2013
September 2008
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • 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
Complete list of historical versions of study NCT00757757 on ClinicalTrials.gov Archive Site
Change in markers of bone resorption and formation (pre- vs. post-treatment) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in markers of bone resorption and formation (pre- vs. post-treatment)
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Bone Metastases
Drug: MCS110
Anti-M-CSF antibody
Experimental: MCS110
Intervention: Drug: MCS110
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
August 2009
August 2009   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00757757
CMCS110A2101
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

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