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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
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of BIIB022

Outcome Time Frame:

ongoing

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

212ST101

NCT ID:

NCT00555724

Start Date:

January 2008

Completion Date:

July 2010

Related Keywords:

  • Solid Tumors
  • Relapsed
  • refractory
  • solid tumor
  • Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteAllentown, Pennsylvania