NCT00956436

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 16, 2013

Status Verified

November 1, 2011

Enrollment Period

1.7 years

First QC Date

August 5, 2009

Last Update Submit

September 12, 2013

Conditions

Hepatocellular Carcinoma

Keywords

Liver CancerHepatocellular CarcinomaSorafenibHCCBIIB022Open-LabelIGF-1RNexavar

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Study Arms (2)

Sorafenib Monotherapy

EXPERIMENTAL

Sorafenib Monotherapy

Drug: Sorafenib

Sorafenib with BIIB022

EXPERIMENTAL

Sorafenib with BIIB022

Drug: BIIB022

Interventions

BIIB022DRUG

IV Q3W

Also known as: IGF-1R, Liver Cancer, Hepatocellular Carcinoma, Monoclonal Antibody, Sorafenib, HCC, Nexavar
Sorafenib with BIIB022
SorafenibDRUG

Standard dosing of Sorafenib

Also known as: HCC, Monoclonal Antibody, Hepatocellular Carcinoma, Liver Cancer, BIIB022, IGF-1R, Nexavar
Sorafenib Monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Resesarch Site

Denver, Colorado, United States

Location

Resesarch Site

Ocoee, Florida, United States

Location

Resesarch Site

Indianapolis, Indiana, United States

Location

Resesarch Site

Boston, Massachusetts, United States

Location

Resesarch Site

New York, New York, United States

Location

Resesarch Site

Norfolk, Virginia, United States

Location

Resesarch Site

Singapore, Singapore

Location

Resesarch Site

Tainan, Taiwan

Location

Resesarch Site

Taipei, Taiwan

Location

Resesarch Site

Taoyuan District, Taiwan

Location

Resesarch Site

Edgbaston, Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsInsulin-Like Growth Factor I, Resistance To

Interventions

BIIB022Receptor Protein-Tyrosine KinasesAntibodies, MonoclonalSorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cell SurfaceMembrane ProteinsAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsPhenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 11, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 16, 2013

Record last verified: 2011-11

Locations

TW(3)US(6)GB(1)SG(1)