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Trial record 1 of 1 for:    Necitumumab, CP11-0401
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Study of IMC-11F8 in Patients With Tumors Who Have Not Responded to Standard Therapy

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ClinicalTrials.gov Identifier: NCT00801177
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 3, 2008
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE November 2004
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2010)
  • Number of Participants with Adverse Events [ Time Frame: Approximately 24 Months ]
  • Maximum Tolerated Dose of IMC-11F8 [ Time Frame: Approximately 24 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Safety Profile and Maximum Tolerated Dose [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2010)
  • Area under the Time Concentration Curve (AUC) [ Time Frame: Approximately 24 Months ]
  • Maximum concentration (Cmax) [ Time Frame: Approximately 24 Months ]
  • Half-life (t 1/2) [ Time Frame: Approximately 24 Months ]
  • Serum Anti-IMC-11F8 Antibody Assessment [ Time Frame: Approximately 24 Months ]
  • Change from baseline in Antitumor Activity [ Time Frame: Approximately 24 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • Pharmacokinetics [ Time Frame: 8 weeks ]
  • Immunogenicity [ Time Frame: 8 weeks ]
  • Antitumor Activity [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IMC-11F8 in Patients With Tumors Who Have Not Responded to Standard Therapy
Official Title  ICMJE 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
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *
  • 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00801177
Other Study ID Numbers  ICMJE 14088
2004-002072-42 ( EudraCT Number )
CP11-0401 ( Other Identifier: ImClone, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chief Medical Officer, ImClone LLC
Original Responsible Party Eric Rowinsky/ Chief Medical Officer, ImClone Systems Incorporated
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: E-mail: ClinicalTrials@ ImClone.com Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date October 2010

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