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Phase I Study of Anti-Insulin-Like Growth Factor-I Receptor (IGF-IR) Monoclonal Antibody IMC-A12 Administered Every Other Week 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
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

Phase I Study of Anti-Insulin-Like Growth Factor-I Receptor (IGF-IR) Monoclonal Antibody IMC-A12 Administered Every Other Week 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 establish the safety profile and maximum tolerated dose
(MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered every other week in
patients with advanced solid tumors who no longer respond to standard therapy or for whom no
standard therapy is available.

Inclusion Criteria


Inclusion Criteria

- Patients with histopathologically-documented, measurable, advanced primary or
recurrent solid tumors who no longer respond to standard therapy or for whom no
standard therapy is available

- A life expectancy of >3 months

- Adequate hematologic function

- Adequate hepatic function

- Adequate renal function

- Use of effective contraception, if procreative potential exists.

- At least 28 days must have elapsed from major surgery, prior chemotherapy, prior
treatment with an investigational agent or device, prior radiation therapy
(palliative radiation therapy is allowed), an open biopsy, or a significant traumatic
injury to allow for adequate recovery

- At least 6 weeks must have elapsed from nitrosoureas, mitomycin C, or monoclonal
antibody therapy to allow for adequate recovery

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

Exclusion Criteria

- 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 for ≥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 (class III or IV of the New York Heart
Association classification for heart disease)

- unstable angina pectoris, angioplasty, stenting, or myocardial infarction within
6 months

- uncontrolled hypertension (systolic blood pressure >160 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 [National Cancer Institute {NCI}-Common Terminology
Criteria for Adverse Events {CTCAE}, Version 3.0, grade 3] or asymptomatic
sustained ventricular tachycardia)

- psychiatric illness/social situations that would compromise patient safety or
limit compliance with study requirements

- patients with symptomatic brain metastases (patients with a history of brain
metastases must be clinically stable and not taking steroids; anticonvulsants
are allowed)

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

- Known human immunodeficiency virus-positive

- A history of a hemorrhagic or thrombotic disorder within 9 months

- Pregnant or breast feeding

- A history of prior treatment with other agents specifically targeting IGFRs.

- Known diabetes

- Inability or unwillingness to interrupt steroidal or hormonal therapy for the
duration of treatment with IMC-A12

- A positive anti-IMC-A12 antibody response

- A 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 of the employees

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of participants with Adverse Events (AEs)

Outcome Time Frame:

8 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:

13933

NCT ID:

NCT00785941

Start Date:

April 2006

Completion Date:

November 2007

Related Keywords:

  • Advanced Solid Tumors
  • Tumors
  • Antibodies, Monoclonal

Name

Location

ImClone Investigational SiteMemphis, Tennessee  38104