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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
October 31, 2007
November 9, 2007
January 9, 2017
January 2008
April 2010   (Final data collection date for primary outcome measure)
To evaluate the safety and tolerability of BIIB022 [ Time Frame: ongoing ]
To evaluate safety.
Complete list of historical versions of study NCT00555724 on ClinicalTrials.gov Archive Site
To evaluate pharmacokinetics [ Time Frame: ongoing ]
  • To evaluate pharmacokinetics
  • To evaluate the immunogenicity
  • To evaluate clinical activity
  • To conduct biomarker studies.
Not Provided
Not Provided
 
Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors
A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
Drug: BIIB022
IV infusion once every three weeks until disease progression or unacceptable toxicity
Other Name: IGF-1R
Experimental: BIIB022
Intervention: Drug: BIIB022
von Mehren M, Britten CD, Pieslor P, Saville W, Vassos A, Harris S, Galluppi GR, Darif M, Wainberg ZA, Cohen RB, Leong S. A phase 1, open-label, dose-escalation study of BIIB022 (anti-IGF-1R monoclonal antibody) in subjects with relapsed or refractory solid tumors. Invest New Drugs. 2014 Jun;32(3):518-25. doi: 10.1007/s10637-014-0064-y. Epub 2014 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
April 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00555724
212ST101
Not Provided
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Not Provided
Biogen
January 2017

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