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Phase I Study of Anti-Insulin-Like Growth Factor-I Receptor (IGF-IR) Monoclonal Antibody IMC-A12 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 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 weekly in patients with
advanced solid tumors who no longer respond to standard therapy or for whom no standard
therapy is available


Inclusion Criteria:



- Histopathologically-documented, measurable, advanced primary or recurrent solid
tumors who no longer respond 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

- Life expectancy of > 3 months

- Adequate hematologic functions, as defined by: ANC ≥ 1500mm3, hemoglobin level ≥ 10
gm/dL, platelet count ≥ 100,000/mm3

- 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

- Ejection fraction within the normal institutional limits

- Use of effective contraception per institutional standard, 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. Ongoing side effects due to these agents must
be ≤ grade 2 prior to entering the study.

- At least 6 weeks must have elapsed from nitrosoureas, mitomycin C, or monoclonal
antibody (not targeting the IGFR) therapy to allow for adequate recovery. Ongoing
side effects due to these agents must be ≤ grade 2 prior to entering the study.

- 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,
unstable angina pectoris, angioplasty, stenting or myocardial infarction within 6
months, uncontrolled hypertension, clinically significant cardiac arrhythmia,
psychiatric illness/social situations that would compromise patient safety or limit
compliance with study requirements, patients with symptomatic brain metastases

- Serious or nonhealing active wound, ulcer or bone fracture

- Know HIV-positive

- History of hemorrhagic or thrombotic disorder within 9 months

- 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

- 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

- Positive anti-IMC-A12 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 of the employees.

Type of Study:

Interventional

Study Design:

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

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:

13932

NCT ID:

NCT00785538

Start Date:

October 2005

Completion Date:

January 2011

Related Keywords:

  • Advanced Solid Tumors
  • Tumors
  • Antibodies, Monoclonal

Name

Location

ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteTucson, Arizona  85712
ImClone Investigational SiteSeattle, Washington  98104