NCT00639509

Brief Summary

This phase II trial is studying how well IMC-A12 works in treating patients with advanced liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

March 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

December 3, 2013

Completed
Last Updated

May 23, 2014

Status Verified

March 1, 2012

Enrollment Period

2.9 years

First QC Date

March 19, 2008

Results QC Date

September 25, 2013

Last Update Submit

May 7, 2014

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (2)

  • PFS Rate

    PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon's optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.

    At 4 months

  • Best Overall Response Rate (ORR)

    Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon's optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.

    From the start of the treatment until disease progression/recurrence

Secondary Outcomes (1)

  • Median Overall Survival

    Post-Treatment

Study Arms (1)

Treatment (monoclonal antibody therapy)

EXPERIMENTAL

Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Biological: cixutumumabProcedure: computed tomographyProcedure: contrast-enhanced magnetic resonance imaging

Interventions

cixutumumabBIOLOGICAL

Given IV

Also known as: anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12
Treatment (monoclonal antibody therapy)
computed tomographyPROCEDURE

Undergo contrast-enhanced computed tomography

Also known as: tomography, computed
Treatment (monoclonal antibody therapy)
contrast-enhanced magnetic resonance imagingPROCEDURE

Undergo contrast-enhanced magnetic resonance imaging

Also known as: Contrast-enhanced MRI
Treatment (monoclonal antibody therapy)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed hepatocellular carcinoma
  • Unresectable, locally advanced, or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Child's Pugh score A5, A6, B7, or B8
  • No known brain metastases
  • No history of primary CNS tumors
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy \> 3 months
  • Leukocytes ≥ 3,000/mcL
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 75,000/mcL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN
  • PT/INR ≤ 1.7 times ULN
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

cixutumumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Ghassan K. Abou-Alfa, MD
Organization
Memorial Sloan-Kettering Cancer Center
abou-alg@mskcc.org
646-888-4184

Study Officials

  • Ghassan Abou-Alfa

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 20, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 23, 2014

Results First Posted

December 3, 2013

Record last verified: 2012-03

Locations

US(1)