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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

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

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 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.

Inclusion Criteria:

1. 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).

2. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 at study

3. Able to provide written informed consent.

4. Age 18 years or older.

5. A life expectancy of >3 months.

6. Adequate hematologic function, as defined by:

- an absolute neutrophil count ≥1500/mm3

- a hemoglobin level ≥ 9gm/dL

- a platelet count ≥100,000/mm3

7. 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

8. Adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN.

9. Use of effective contraception (per the institutional standard), if procreative
potential exists.

10. 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).

11. Accessible for treatment and follow-up. Patients enrolled in this trial must be
treated at the participating center.

Exclusion Criteria:

1. 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.

2. 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

- 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

3. 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).

4. A serious or nonhealing active wound, ulcer, or bone fracture.

5. Known human immunodeficiency virus positivity.

6. A major surgical procedure, an open biopsy, or a significant traumatic injury within
28 days prior to treatment.

7. Current or recent use (within 28 days) of a thrombolytic agent.

8. 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.

9. 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).

10. A history or clinical evidence of a deep venous or arterial thrombosis (including
pulmonary embolism) within 6 months prior to study entry.

11. 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.

12. Pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]) or breast

13. Positive for anti-IMC-18F1 antibodies.

14. Treatment with monoclonal antibodies within 6 weeks of study entry.

15. A history of allergic reactions to monoclonal antibodies or other therapeutic

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

November 2009

Related Keywords:

  • Advanced Solid Tumors
  • Solid Tumors
  • VEGF-A
  • stromal cells
  • endothelial cells
  • malignant cells
  • Neoplasms



ImClone Investigational Site Ypsilanti, Michigan  48198
ImClone Investigational Site Cleveland, Ohio  44134