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OpenTrials
Completed

NCT Number: NCT00555724

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

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

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Key information

Conditions

Solid Tumors Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB022

Drug

IV infusion once every three weeks until disease progression or unacceptable toxicity

Other names: IGF-1R

Primary outcomes

  1. To evaluate the safety and tolerability of BIIB022

    Time frame: ongoing

Secondary outcomes

  1. To evaluate pharmacokinetics

    Time frame: ongoing

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 9, 2007
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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