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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555724
First Posted: November 9, 2007
Last Update Posted: January 9, 2017
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.
Information provided by (Responsible Party):
Biogen
  Purpose
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Condition Intervention Phase
Solid Tumors Drug: BIIB022 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biogen:

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

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

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB022 Drug: BIIB022
IV infusion once every three weeks until disease progression or unacceptable toxicity
Other Name: IGF-1R

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00555724


Locations
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
Biogen
  More Information

Publications:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00555724     History of Changes
Other Study ID Numbers: 212ST101
First Submitted: October 31, 2007
First Posted: November 9, 2007
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Biogen:
Relapsed
refractory
solid tumor

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