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Clinical Trials/NCT00555724
NCT00555724
Completed
Phase 1

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

Biogen1 site in 1 country40 target enrollmentJanuary 2008
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ConditionsSolid Tumors
InterventionsBIIB022
DrugsBIIB022

Overview

Phase
Phase 1
Intervention
BIIB022
Conditions
Solid Tumors
Sponsor
Biogen
Enrollment
40
Locations
1
Primary Endpoint
To evaluate the safety and tolerability of BIIB022
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
July 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Biogen
Responsible Party
Sponsor

Eligibility 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.

Arms & Interventions

BIIB022

Intervention: BIIB022

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of BIIB022

Time Frame: ongoing

Secondary Outcomes

  • To evaluate pharmacokinetics(ongoing)

Study Sites (1)

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