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
18 Years
N/A
Not Enrolling
Both
Solid Tumors
Both
Solid Tumors
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 Site | Anaheim, California |
| Research Site | Boulder, Colorado |
| Research Site | Allentown, Pennsylvania |
