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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
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Biological: IMC-11F8
Biological: IMC-11F8 I.V.
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: November 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-11F8 (Every week)
Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.
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
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.
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

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801177

Locations
Netherlands
ImClone Investigational Site
Amsterdam, Netherlands, 1081 HV
ImClone Investigational Site
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
ImClone LLC
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

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.

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00801177     History of Changes
Other Study ID Numbers: 14088, 2004-002072-42, CP11-0401
Study First Received: December 2, 2008
Last Updated: October 11, 2010
Health Authority: United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ImClone LLC:
Tumors
Antibodies, Monoclonal

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014