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Advanced Solid TumorsPhase 1NCT00782002

Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard Therapy

A Phase 1 study testing IMC-18F1 in people with Advanced Solid Tumors, run by Eli Lilly and Company at 2 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine if IMC-18F1 is safe for patients, and also to determine the best dose of IMC-18F1 to give to patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
IMC-18F1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesUnited States
Study dates
Jul 2006to Nov 2009
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

  • Patients with histopathologically-documented, measurable or non measurable {evaluable}, advanced solid tumors refractory to standard therapy or for which no standard therapy is available (see Section 10.2, Tumor Response, for the definition of measurable and non measurable {evaluable} disease).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 at study entry.
  • Able to provide written informed consent.
  • Age 18 years or older.
  • A life expectancy of >3 months.
  • Adequate hematologic function, as defined by:
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  • an absolute neutrophil count ≥1500/mm3
  • a hemoglobin level ≥ 9gm/dL
  • a platelet count ≥100,000/mm3
  • Adequate hepatic function, as defined by:
  • a total 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 if known liver metastases
  • Adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN.
  • Use of effective contraception (per the institutional standard), if procreative potential exists.
  • Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy (palliative radiation therapy is allowed).
  • Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.

Who cannot join

  • Patients who have had chemotherapy or therapeutic radiotherapy within 28 days prior to entering the study or patients with ongoing side effects ≥ grade 2 due to agents administered more than 28 days earlier.
  • Uncontrolled intercurrent illness including, but not limited to:
  • ongoing or active infection requiring parenteral antibiotics
  • symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)
  • left ventricular ejection fraction (LVEF) of <50%. If a baseline MUGA shows a <50% ejection fraction, then a confirmatory ultrasound should be performed. If it is <50%, the patient is excluded from the study
  • unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
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  • uncontrolled hypertension (systolic blood pressure >150 mm Hg, diastolic blood pressure >100 mm Hg, found on two consecutive measurements separated by a 1-week period despite adequate medical support)
  • clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [Common Terminology Criteria for Adverse Events {CTCAE}, Version 3.0, grade 3] or asymptomatic sustained ventricular tachycardia)
  • uncontrolled diabetes
  • psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
  • Patients with progressive or symptomatic brain or leptomeningeal metastases. (Patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids; anti-seizure medications are allowed).
  • A serious or nonhealing active wound, ulcer, or bone fracture.
  • Known human immunodeficiency virus positivity.
  • A major surgical procedure, an open biopsy, or a significant traumatic injury within 28 days prior to treatment.
  • Current or recent use (within 28 days) of a thrombolytic agent.
  • Current use of full-dose warfarin (an exception is low-dose warfarin to maintain patency of pre-existing, permanent, indwelling intravenous (i.v.) catheters; for patients receiving warfarin, the international normalized ratio [INR] should be <1.5), heparin or fractionated heparin are excluded.
  • Chronic daily treatment with aspirin (>325 mg/day), nonsteroidal antiinflammatory or other medications known to inhibit platelet function (cyclooxygenase-2 [COX-2] inhibitors are permitted).
  • A history or clinical evidence of a deep venous or arterial thrombosis (including pulmonary embolism) within 6 months prior to study entry.
  • Proteinuria ≥2+ by routine urinalysis or dipstick and subsequent documentation by 24-hour urine collection of >1 g protein. Patients with genitourinary malignancies and/or those with a requirement for urinary catheters or stents will be excluded if the 24-hour urine protein is ≥2 g.
  • Pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]) or breast feeding.
  • Positive for anti-IMC-18F1 antibodies.
  • Treatment with monoclonal antibodies within 6 weeks of study entry.
  • A history of allergic reactions to monoclonal antibodies or other therapeutic proteins.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • ImClone Investigational Site

    Cleveland, Ohio, 44106

  • ImClone Investigational Site

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Phase 1 Study of Weekly Anti-Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) Monoclonal Antibody IMC-18F1 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or For Whom No Standard Therapy is Available

The purpose of this study is to determine if IMC-18F1 is safe for patients, and also to determine the best dose of IMC-18F1 to give to patients.

Read the detailed description

The purpose of this study will be to establish the safety profile and the maximum tolerated dose (MTD) of the anti-VEGFR-1 monoclonal antibody IMC-18F1 administered weekly, every other week, or every three weeks in patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.

Being tested
IMC-18F1
Keywords
Solid Tumors, VEGF-A, stromal cells, endothelial cells, malignant cells

What participants receive

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

  • IMC-18F1Biological

    Cohorts 1-4 will receive IMC-18F1 intravenously for 4 weekly infusions, followed by a 2-week observation period. Cohort 5 will receive IMC-18F1 intravenously every other week for the first 6 weeks of therapy. Cohort 6 will receive IMC-18F1 every 3 weeks for the first 6 weeks for therapy. The starting dose in Cohort 1 will be 2mg/kg. The maximum dose of IMC-18F1 will not exceed 16mg/kg administered every week, 15mg/kg administered every other week, and 20mg/kg administered every 3 weeks. Dose escalation of 100% (2 x previous dose) if no dose limiting toxicities (DLTs) are observed in the first three patients within a cohort during the initial 6-week therapy period. Dose escalation increment will be reduced to 50% (1.5 x previous dose) following the occurrence of either grade 2 or higher AEs in 2 or more patients that are possibly, probably, or definitely-related to study medication or one DLT during the initial 6-week therapy period. No intrapatient dose escalation is allowed.

Study groups in NCT00782002
Study groupRoleWhat they receive
IMC-18F1ExperimentalNot described
Receives: Biological: IMC-18F1

What is being measured

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

  1. Maximum Tolerated Dose

    Measured: 6 weeks

Secondary outcomes (3)

  1. Pharmacokinetics

    Measured: 6 weeks

  2. Antitumor Activity of IMC-18F1 Monotherapy

    Measured: 6 Weeks

  3. Pharmacodynamics

    Measured: 6 Weeks

Timeline

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

  1. First posted29 Oct 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionMar 2009
  4. Study completionNov 2009

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00782002
Sponsor's protocol ID
13941
Other IDs
CP14-0501, I4Y-IE-JCDA
Status last verified
Sep 2010
First submitted
27 Oct 2008
Last updated
30 Sep 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • LoRusso PM, Krishnamurthi S, Youssoufian H, Hall N, Fox F, Dontabhaktuni A, Grebennik D, Remick S. Icrucumab, a fully human monoclonal antibody against the vascular endothelial growth factor receptor-1, in the treatment of patients with advanced solid malignancies: a Phase 1 study. Invest New Drugs. 2014 Apr;32(2):303-11. doi: 10.1007/s10637-013-9998-8. Epub 2013 Aug 1.

    PubMed 23903897

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMC-18F1 in people with Advanced Solid Tumors, run by Eli Lilly and Company at 2 sites in United States.

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 16 inclusion and 23 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 30 Sep 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 United States. 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?

Maximum Tolerated Dose (time frame: 6 weeks). 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 NCT00782002, which also lists 1 linked publication.

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 30 Sep 2010.

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