AzTrials
AzTrials

Solid TumorsPhase 1NCT00801177

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

A Phase 1 study testing IMC-11F8 and IMC-11F8 I.V. in people with Solid Tumors, run by Eli Lilly and Company at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
IMC-11F8 and IMC-11F8 I.V.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesNetherlands
Study dates
Nov 2004to Feb 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • ImClone Investigational Site

    Amsterdam, 1081 HV

  • ImClone Investigational Site

    Utrecht, 3508 GA

Other trials in Netherlands

About this study

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

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.

Read the 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.

Conditions
Solid Tumors
Being tested
IMC-11F8, IMC-11F8 I.V.
Keywords
Tumors, Antibodies, Monoclonal
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 1

    100 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 2

    200 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 3

    400 mg I.V.

  • IMC-11F8 I.V.Biological

    Also called necitumumab

    Cohort 4

    600 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 5

    800 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 6

    1000 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 1

    100 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 2

    200 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 3

    400 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 4

    600 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 5

    800 mg I.V.

  • IMC-11F8Biological

    Also called necitumumab

    Cohort 6

    1000 mg I.V.

Study groups in NCT00801177
Study groupRoleWhat they receive
IMC-11F8 (Every week)ExperimentalCycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.
Receives: Biological: IMC-11F8; Biological: IMC-11F8 I.V.
IMC-11F8 (Every other week)ExperimentalCycle of therapy administered intravenously, every other week for 6 weeks, for a total of three doses per cycle.
Receives: Biological: IMC-11F8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

    Measured: Approximately 24 Months

  2. Maximum Tolerated Dose of IMC-11F8

    Measured: Approximately 24 Months

Secondary outcomes (5)

  1. Area under the Time Concentration Curve (AUC)

    Measured: Approximately 24 Months

  2. Maximum concentration (Cmax)

    Measured: Approximately 24 Months

  3. Half-life (t 1/2)

    Measured: Approximately 24 Months

  4. Serum Anti-IMC-11F8 Antibody Assessment

    Measured: Approximately 24 Months

  5. Change from baseline in Antitumor Activity

    Measured: Approximately 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2008 (estimated)
  2. Study startNov 2004
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801177
Sponsor's protocol ID
14088
Other IDs
2004-002072-42, CP11-0401, 2004
Status last verified
Oct 2010
First submitted
2 Dec 2008
Last updated
13 Oct 2010
Results posted
No
Data monitoring committee
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMC-11F8 and IMC-11F8 I.V. in people with Solid Tumors, run by Eli Lilly and Company at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: Approximately 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801177, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in