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

Tracking Information

First Received Date ^ICMJE

October 31, 2007

Last Updated Date

July 10, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of BIIB022 [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To evaluate safety.

Change History

Complete list of historical versions of study NCT00555724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate pharmacokinetics [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To evaluate pharmacokinetics
To evaluate the immunogenicity
To evaluate clinical activity
To conduct biomarker studies.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Solid Tumors

Intervention ^ICMJE

Drug: BIIB022

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Biogen Idec

oncologyclinicaltrials@biogenidec.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00555724

Responsible Party

Study MD, Biogen Idec

Study ID Numbers ^ICMJE

212ST101

Study Sponsor ^ICMJE

Biogen Idec

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Biogen Idec

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP