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NCT00555724 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00555724
Other study ID # 212ST101
Secondary ID
Status Completed
Phase Phase 1
First received October 31, 2007
Last updated January 5, 2017
Start date January 2008
Est. completion date July 2010

Study information
Verified date January 2017
Source Biogen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• BIIB022
IV infusion once every three weeks until disease progression or unacceptable toxicity

Locations
Country Name City State
United States Research Site Aurora Colorado
United States Research Site Los Angeles California
United States Research Site Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

United States, 

References & Publications (1)

von Mehren M, Britten CD, Pieslor P, Saville W, Vassos A, Harris S, Galluppi GR, Darif M, Wainberg ZA, Cohen RB, Leong S. A phase 1, open-label, dose-escalation study of BIIB022 (anti-IGF-1R monoclonal antibody) in subjects with relapsed or refractory solid tumors. Invest New Drugs. 2014 Jun;32(3):518-25. doi: 10.1007/s10637-014-0064-y. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of BIIB022 ongoing Yes
Secondary To evaluate pharmacokinetics ongoing No
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