Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00100685
First received: January 4, 2005
Last updated: April 25, 2012
Last verified: April 2012

January 4, 2005
April 25, 2012
January 2005
December 2007   (final data collection date for primary outcome measure)
The proportion of patients with a confirmed tumor response at any time during the study [ Time Frame: Any time during the study ] [ Designated as safety issue: No ]
The proportion of patients with a confirmed tumor response at any time during the study
Complete list of historical versions of study NCT00100685 on ClinicalTrials.gov Archive Site
  • Time to disease progression [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
  • Duration of tumor response [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK) of M200 [ Time Frame: Day 0 through Study Termination ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Day 0 through Study Termination ] [ Designated as safety issue: No ]
  • Time to disease progression
  • Duration of tumor response
  • Pharmacokinetics (PK) of M200
  • Immunogenicity
Not Provided
Not Provided
 
Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Cell Carcinoma
  • Metastases
Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)
Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
  • Experimental: Arm 1
    Volociximab administered intravenously at a dose of 10 mg/kg qowk
    Intervention: Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)
  • Experimental: Arm 2
    Volociximab administered intravenously at a dose of 15 mg/kg qwk
    Intervention: Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
48
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
  • Measurable disease according to Response Criteria for Solid Tumors.
  • Negative pregnancy test (women of childbearing potential only).
  • Pretreatment laboratory levels that meet specific criteria.
  • Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
  • Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).

Exclusion Criteria

  • Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
  • Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
  • Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
  • Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
  • Documented central nervous system (CNS) tumor or CNS metastasis.
  • History of thromboembolic events and bleeding disorders within the past year.
  • Medical conditions that may be exacerbated by bleeding.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100685
M200-1204
Yes
Abbott
Abbott
Not Provided
Study Director: Mihail Obrocea, MD Abbott
Abbott
April 2012

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