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

NCT00801177 | Completed Phase 1

• 3 other identifiers: 140882004-002072-42CP11-0401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Tumors; Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  Approximately 24 Months

• Maximum Tolerated Dose of IMC-11F8

  Approximately 24 Months

Secondary Outcomes (5)

• Area under the Time Concentration Curve (AUC)

  Approximately 24 Months

• Maximum concentration (Cmax)

  Approximately 24 Months

• Half-life (t 1/2)

  Approximately 24 Months

• Serum Anti-IMC-11F8 Antibody Assessment

  Approximately 24 Months

• Change from baseline in Antitumor Activity

  Approximately 24 Months

Study Arms (2)

IMC-11F8 (Every week)

EXPERIMENTAL

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

Biological: IMC-11F8; Biological: IMC-11F8 I.V.

IMC-11F8 (Every other week)

EXPERIMENTAL

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

Biological: IMC-11F8

Interventions

IMC-11F8 BIOLOGICAL

Cohort 1 100 mg I.V.

Also known as: necitumumab

IMC-11F8 (Every week)

IMC-11F8 I.V. BIOLOGICAL

Cohort 4 600 mg I.V.

Also known as: necitumumab

IMC-11F8 (Every week)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

ImClone Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

ImClone Investigational Site

Utrecht, 3508 GA, Netherlands

Location

Related Publications (2)

• 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.

  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.

  RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

necitumumab

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: November 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

NL (2)