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

NCT ID: NCT00100685

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-12-31

Brief 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.

Conditions

Renal Cell Carcinoma; Metastases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Volociximab administered intravenously at a dose of 10 mg/kg qowk

Group Type: EXPERIMENTAL

Volociximab (anti-α5β1 integrin monoclonal antibody)

Intervention Type: DRUG

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.

Arm 2

Volociximab administered intravenously at a dose of 15 mg/kg qwk

Group Type: EXPERIMENTAL

Volociximab (anti-α5β1 integrin monoclonal antibody)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihail Obrocea, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 70400

Los Angeles, California, United States

Site Reference ID/Investigator# 70401

New York, New York, United States

Site Reference ID/Investigator# 70399

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

M200-1204

Identifier Type: -

Identifier Source: org_study_id

NCT00103077

Identifier Type: -

Identifier Source: nct_alias