MedDataX Logo

Study of IMC-11F8 in Patients With Tumors Who Have Not Responded to Standard Therapy

NCT ID: NCT00801177

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if IMC-11F8 is safe for patients, and also to determine the best dose of IMC-11F8 to give to patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to establish the safety profile and the maximum tolerated dose (MTD) of the fully human anti-EGFR monoclonal antibody IMC-11F8 in patients with solid tumors who have filed standard therapy or for whom no standard therapy is available.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMC-11F8 (Every week)

Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.

Group Type EXPERIMENTAL

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 1

100 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 2

200 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 3

400 mg I.V.

IMC-11F8 I.V.

Intervention Type BIOLOGICAL

Cohort 4

600 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 5

800 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 6

1000 mg I.V.

IMC-11F8 (Every other week)

Cycle of therapy administered intravenously, every other week for 6 weeks, for a total of three doses per cycle.

Group Type EXPERIMENTAL

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 1

100 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 2

200 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 3

400 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 4

600 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 5

800 mg I.V.

IMC-11F8

Intervention Type BIOLOGICAL

Cohort 6

1000 mg I.V.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IMC-11F8

Cohort 1

100 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 2

200 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 3

400 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8 I.V.

Cohort 4

600 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 5

800 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 6

1000 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 1

100 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 2

200 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 3

400 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 4

600 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 5

800 mg I.V.

Intervention Type BIOLOGICAL

IMC-11F8

Cohort 6

1000 mg I.V.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab necitumumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically-confirmed, EGFR-detectable or EGFR-undetectable, unidimensionally-measurable and/or evaluable solid tumors who failed standard therapy or for whom no standard therapy is available. Patients who do not have tissue available for EGFR testing will undergo a biopsy of an accessible tumor.
* ECOG performance status score of ≤ 2 at study entry.
* Able to provide written informed consent.
* White blood cell (WBC) count ≥ 3 x 109/L; an absolute neutrophil count ≥ 1.5 x 109/L; a hemoglobin level \> 90 g/L; and a platelet count ≥ 100 x 109/L.
* Adequate hepatic function as defined by:

* an alkaline phosphatase level ≤ 5.0 x the ULN
* a bilirubin level ≤ 1.5 x the ULN
* aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN for patients with liver metastases
* Adequate renal function as defined by a serum creatinine level within normal limits.
* Use of effective contraception if procreative potential exists.
* Life expectancy of approximately 3 months in the opinion the opinion of the investigator.

Exclusion Criteria

* Chemotherapy, radiation, and/or hormonal therapy (except palliative radiation therapy for disease-related pain and chronic hormonal therapy for prostate carcinoma) within 4 weeks of study entry.
* Concurrent unstable or uncontrolled medical disease (e.g., active uncontrolled systemic infection, poorly controlled hypertension or history of poor compliance with an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled diabetes) or other chronic disease, which, in the opinion of the investigator, could compromise the patient or the study.
* Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids; anticonvulsants are allowed).
* Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3 years will be allowed to enter the trial.
* Any condition that prevents the patient from providing informed consent.
* Pregnancy (confirmed by serum beta human chorionic gonadotropin \[ßHCG\]) or breast-feeding.
* Any investigational agent(s) or device(s) within 4 weeks of study entry.
* Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted ≥ 4 weeks prior to study entry.
* Any prior therapy that targeted the EGFR or EGFR pathway.
* Known history of human immunodeficiency virus.
* Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ImClone LLC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

E-mail: ClinicalTrials@ ImClone.com

Role: STUDY_CHAIR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ImClone Investigational Site

Amsterdam, , Netherlands

Site Status

ImClone Investigational Site

Utrecht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Kuenen B, Witteveen E, Ruijter R, Ervin-Haynes A, Tjin-A-ton M, Fox F, et al. A phase I study of IMC-11F8, a fully human anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody in patients with solid tumors. Interim results. [abstract 3024 and poster presentation]. American Society of Clinical Oncology Annual Meeting. 2006 June 2-6; Atlanta, GA.

Reference Type RESULT

Kuenen B, Witteveen PO, Ruijter R, Tjin-A-Ton M, Youssoufian H, Rowinsky E, et al. A phase I study of IMC-11F8, a recombinant human anti-epidermal growth factor receptor IgG1 monoclonal antibody in patients with solid tumors. [abstract B52 and poster presentaton] International Conference on Molecular Targets and Cancer Therapeutics 2007 Oct 22-26; San Francisco, CA.

Reference Type RESULT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-002072-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CP11-0401

Identifier Type: OTHER

Identifier Source: secondary_id

14088

Identifier Type: -

Identifier Source: org_study_id