Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC) | NCT00956436

Studies
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

NCT00956436

Sponsor

Biogen

Status

Completed

Last Update Posted

Sep 16, 2013Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Hepatocellular Carcinoma

Interventions

BIIB022
Sorafenib

Countries

United States
Singapore
Taiwan
United Kingdom

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

Nov 2011

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

Aug 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Aug 5, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

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

Sep 12, 2013

Last Update Posted Date

Sep 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

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
Sorafenib Monotherapy	Experimental	Sorafenib Monotherapy	Drug: Sorafenib
Sorafenib with BIIB022	Experimental	Sorafenib with BIIB022	Drug: BIIB022

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIIB022	Drug	IV Q3W	Sorafenib with BIIB022	IGF-1R Liver Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.		6 months

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the PK profile of BIIB022 and sorafenib in this study population		6 months
To assess the anti-tumor response in this study population		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years
Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
Child-Pugh score A5 or A6.
ECOG Performance Status of ≤2.

Exclusion Criteria:

Known central nervous system or brain metastases.
Prior anti-IGF-1R therapy.
Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
Concurrent anticancer therapy.
History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
Acute hepatitis
Fibrolamellar HCC

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
Resesarch Site		Denver	Colorado		United States
Resesarch Site

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms
C564816	Insulin-Like Growth Factor I, Resistance To

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000594951	BIIB022
D020794	Receptor Protein-Tyrosine Kinases
D000911	Antibodies, Monoclonal
D000077157	Sorafenib

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided