Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody... | NCT00555724

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

NCT00555724

Sponsor

Biogen

Status

Completed

Last Update Posted

Jan 9, 2017Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Solid Tumors

Interventions

BIIB022

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Apr 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2017

Last Update Posted Date

Jan 9, 2017Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIIB022	Experimental		Drug: BIIB022

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIIB022	Drug	IV infusion once every three weeks until disease progression or unacceptable toxicity	BIIB022

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety and tolerability of BIIB022		ongoing

Secondary Outcomes

Measure	Description	Time Frame
To evaluate pharmacokinetics		ongoing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Los Angeles	California		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24458261	Background	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000594951	BIIB022
D020794	Receptor Protein-Tyrosine Kinases

ID	Term
D011505	Protein-Tyrosine Kinases
D011494	Protein Kinases
D017853	Phosphotransferases (Alcohol Group Acceptor)
D010770	Phosphotransferases