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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00555724
First received: October 31, 2007
Last updated: June 7, 2012
Last verified: January 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 Idec:

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

Secondary Outcome Measures:
  • To evaluate pharmacokinetics [ Time Frame: ongoing ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Idec
  More Information

No publications provided

Responsible Party: Study MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00555724     History of Changes
Other Study ID Numbers: 212ST101
Study First Received: October 31, 2007
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Relapsed
refractory
solid tumor

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

ClinicalTrials.gov processed this record on April 20, 2014