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

Renal Cell Carcinoma Clinical Trial

Official title:

Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00100685
• Other study ID #: M200-1204
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2005
• Last updated: April 25, 2012
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00103077

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastases
• Renal Cell Carcinoma

Intervention

Drug:
• Volociximab (anti-a5ß1 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.

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 70399	Cleveland	Ohio
United States	Site Reference ID/Investigator# 70400	Los Angeles	California
United States	Site Reference ID/Investigator# 70401	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with a confirmed tumor response at any time during the study		Any time during the study	No
Secondary	Time to disease progression		Up to 104 weeks	No
Secondary	Duration of tumor response		Up to 104 weeks	No
Secondary	Pharmacokinetics (PK) of M200		Day 0 through Study Termination	No
Secondary	Immunogenicity		Day 0 through Study Termination	No