Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555724
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : January 9, 2017
Information provided by (Responsible Party):

Brief Summary:
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: BIIB022 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: BIIB022 Drug: BIIB022
IV infusion once every three weeks until disease progression or unacceptable toxicity
Other Name: IGF-1R

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of BIIB022 [ Time Frame: ongoing ]

Secondary Outcome Measures :
  1. To evaluate pharmacokinetics [ Time Frame: ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older at the time of informed consent
  • Relapsed or refractory solid tumors following standard therapy.
  • ECOG Performance Status 0 or 1.

Exclusion Criteria:

  • History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening.
  • History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
  • Known central nervous system or brain metastases.
  • Prior anti-IGF-1R therapy of any kind.

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00555724

United States, California
Research Site
Los Angeles, California, United States
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators

Responsible Party: Biogen Identifier: NCT00555724     History of Changes
Other Study ID Numbers: 212ST101
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Biogen:
solid tumor

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs