Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors
A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors
1 other identifier
interventional
40
1 country
3
Brief Summary
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2008
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2007
CompletedFirst Posted
Study publicly available on registry
November 9, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJanuary 9, 2017
January 1, 2017
2.2 years
October 31, 2007
January 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of BIIB022
ongoing
Secondary Outcomes (1)
To evaluate pharmacokinetics
ongoing
Study Arms (1)
BIIB022
EXPERIMENTALInterventions
IV infusion once every three weeks until disease progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (3)
Research Site
Los Angeles, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Philadelphia, Pennsylvania, United States
Related 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. Epub 2014 Jan 24.
PMID: 24458261BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2007
First Posted
November 9, 2007
Study Start
January 1, 2008
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
January 9, 2017
Record last verified: 2017-01