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
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Bone Metastases
Drug: MCS110
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 3
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCS110 Drug: MCS110
Anti-M-CSF antibody

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757757

Locations
United States, Nevada
NV Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, Texas
CTRC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00757757     History of Changes
Other Study ID Numbers: CMCS110A2101
Study First Received: September 21, 2008
Last Updated: February 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Prostate cancer
bone metastases
anti-M-CSF
M-CSF antibody
M-CSF
Prostate Cancer with bone metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014