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

This study has been completed.
Sponsor:
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00801177
First received: December 2, 2008
Last updated: October 11, 2010
Last verified: October 2010

December 2, 2008
October 11, 2010
November 2004
February 2007   (final data collection date for primary outcome measure)
  • Number of Participants with Adverse Events [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: Yes ]
  • Maximum Tolerated Dose of IMC-11F8 [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: Yes ]
Safety Profile and Maximum Tolerated Dose [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00801177 on ClinicalTrials.gov Archive Site
  • Area under the Time Concentration Curve (AUC) [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: No ]
  • Serum Anti-IMC-11F8 Antibody Assessment [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: No ]
  • Change from baseline in Antitumor Activity [ Time Frame: Approximately 24 Months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Antitumor Activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of IMC-11F8 in Patients With Tumors Who Have Not Responded to Standard Therapy
Phase I Study of the Fully Human Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody IMC-11F8 in Patients With Solid Tumors Who Have Failed Standard Therapy

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Solid Tumors
  • Biological: IMC-11F8

    Cohort 1

    100 mg I.V.

    Other Name: necitumumab
  • Biological: IMC-11F8

    Cohort 2

    200 mg I.V.

    Other Name: necitumumab
  • Biological: IMC-11F8

    Cohort 3

    400 mg I.V.

    Other Name: necitumumab
  • Biological: IMC-11F8 I.V.

    Cohort 4

    600 mg I.V.

    Other Name: necitumumab
  • Biological: IMC-11F8

    Cohort 5

    800 mg I.V.

    Other Name: necitumumab
  • Biological: IMC-11F8

    Cohort 6

    1000 mg I.V.

    Other Name: necitumumab
  • Biological: IMC-11F8

    Cohort 4

    600 mg I.V.

    Other Name: necitumumab
  • Experimental: IMC-11F8 (Every week)
    Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.
    Interventions:
    • Biological: IMC-11F8
    • Biological: IMC-11F8
    • Biological: IMC-11F8
    • Biological: IMC-11F8 I.V.
    • Biological: IMC-11F8
    • Biological: IMC-11F8
  • Experimental: IMC-11F8 (Every other week)
    Cycle of therapy administered intravenously, every other week for 6 weeks, for a total of three doses per cycle.
    Interventions:
    • Biological: IMC-11F8
    • Biological: IMC-11F8
    • Biological: IMC-11F8
    • Biological: IMC-11F8
    • Biological: IMC-11F8
    • Biological: IMC-11F8
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2007
February 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00801177
14088, 2004-002072-42, CP11-0401
No
Chief Medical Officer, ImClone LLC
ImClone LLC
Not Provided
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
ImClone LLC
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP