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

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: BIIB022

• Registration Number: NCT00555724
• Lead Sponsor: Biogen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-11-08
• Study First Posted: 2007-11-09
• Study Start: 2008-01
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIIB022	BIIB022	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of BIIB022	ongoing

Secondary Outcome Measures

Name	Time	Method
To evaluate pharmacokinetics	ongoing

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States