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Phase I Study of Weekly Anti-Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Monoclonal Antibody IMC-1121B in Patients With Advanced Solid Tumors Who Have Not Responded to Standard Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

Phase I Study of Weekly Anti-Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Monoclonal Antibody IMC-1121B in Patients With Advanced Solid Tumors Who Have Not Responded to Standard Therapy


The purpose of this study is to establish the safety profile and the maximum tolerated dose
(MTD) of the anti-VEGFR-2 monoclonal antibody IMC-1121B administered weekly in patients with
advanced solid tumors who have not responded to standard therapy or for whom no standard
therapy is available.


Inclusion Criteria:



- Histopathologically-documented, measurable or evaluable (non-measurable), advanced
primary or recurrent solid tumors who have not responded to standard therapy or for
whom no standard therapy is available.

- ECOG performance status score of ≤ 2 at study entry

- Able to provide written informed consent

- A life expectancy of > 3 months

- Adequate hematologic function, as defined by: ANC ≥ 1500/mm^3, hemoglobin level ≥ 10
gm/dL, platelet count ≥ 100,000/mm^3

- Adequate hepatic function, as defined by: total bilirubin level ≤ 1.5 x the ULN, AST
and 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.

Exclusion Criteria:

- Patients with large centrally-located pulmonary lesions adjacent to or invading large
blood vessels.

- Patients who have had chemotherapy or therapeutic radiotherapy within 28 days (6
weeks for nitrosoureas or mitomycin C) prior to entering the study or patients with
ongoing side effects ≥ grade 2 due to agents administered more than 28 days earlier.

- Prior left chest wall radiotherapy or a cumulative anthracycline dose ≥ 300mg/m2 (if
the ejection fraction is within normal institutional limits, the patient can be
enrolled).

- Any concurrent malignancy other than non-melanomatous skin cancer or carcinoma in
situ of the cervix. Patients with a previous malignancy but without evidence of
disease ≥ 3 years will be allowed to enter the trial.

- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection requiring parenteral antibiotics, symptomatic congestive heart failure,
unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6
months, uncontrolled hypertension, clinically significant cardiac arrhythmia,
uncontrolled diabetes, psychiatric illness/social situations that would compromise
patient safety or limit compliance with study requirements, patients with symptomatic
brain metastases

- A serious or nonhealing active wound, ulcer, or bone fracture

- Known HIV positivity

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

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

- Current or recent use (within 28 days) of full-dose warfarin

- Chronic daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory
medications known to inhibit platelet function

- History or clinical evidence of a deep venous or arterial thrombosis (including
pulmonary embolism) within 6 months prior to study entry

- Proteinuria ≥1+ by routine urinalysis (patients with a protein value of ≤ 500mg
confirmed by a 24-hour urine collection are eligible)

- Pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]) or breast
feeding

- Prior treatment with bevacizumab or other agents specifically targeting VEGF ligand
or receptor within 6 weeks of study entry

- Monoclonal antibodies within 6 weeks of study entry

- Positive anti-IMC-1121B antibody response

- History of allergic reactions to monoclonal antibodies or other therapeutic proteins

- 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 the employees.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of participants with Adverse Events (AEs)

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13918

NCT ID:

NCT00793975

Start Date:

January 2005

Completion Date:

June 2009

Related Keywords:

  • Advanced Solid Tumors
  • Tumors
  • Antibodies, Monoclonal

Name

Location

ImClone Investigational SiteDenver, Colorado  80262
ImClone Investigational SitePhiladelphia, Pennsylvania  19107