A Study of IMC-A12 Every 2 Weeks in Patients With Tumors Who No Longer Respond to Treatment or No Treatment is Available

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The purpose of this study is to determine if IMC-A12 is safe for patients, and also to determine the best dose of IMC-A12 to give to patients.

Key facts

Study ID

NCT00785941

Run by

Eli Lilly and Company

People needed

16

Starts

2006-04-01

Expected to finish

2007-11-01

Last updated by the study team

2011-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ImClone Investigational Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.