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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIIB022

Group Type EXPERIMENTAL

BIIB022

Intervention Type DRUG

IV infusion once every three weeks until disease progression or unacceptable toxicity

Interventions

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BIIB022

IV infusion once every three weeks until disease progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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IGF-1R

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No