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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2005

Last Updated Date

April 25, 2012

Start Date ^ICMJE

January 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The proportion of patients with a confirmed tumor response at any time during the study

Change History

Complete list of historical versions of study NCT00100685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Time to disease progression
Duration of tumor response
Pharmacokinetics (PK) of M200
Immunogenicity

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Renal Cell Carcinoma
Metastases

Intervention ^ICMJE

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.

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00100685

Other Study ID Numbers ^ICMJE

M200-1204

Has Data Monitoring Committee

Yes

Responsible Party

Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Mihail Obrocea, MD

Abbott

Information Provided By

Abbott

Verification Date

April 2012

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

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