Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to determine if IMC-3G3 is safe for patients, and also to determine the best dose of IMC-3G3 to give to patients.

Key facts

Study ID

NCT00768391

Run by

Eli Lilly and Company

People needed

20

Starts

2006-12-01

Expected to finish

2010-01-01

Last updated by the study team

2011-06-28

Who can join

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

You may qualify if…

• Histopathological-documented, measurable, or non measurable, advanced primary tumor or recurrent solid tumor or lymphoma unresponsive to standard therapy or for which there is no standard therapy available.
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry.
• Able to provide written informed consent.
• Age 18 years or older.
• Life expectancy of > 3 months.
• Adequate hematologic function, as defined by: an absolute neutrophil count ≥ 1500/mm3; a platelet count ≥ 100,000/mm3
• Adequate hepatic function, as defined by: a total bilirubin level ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN if known liver metastases
• Adequate renal function, as defined by serum creatinine level ≤ 1.5 x the ULN.
• Uses effective contraception (per the institutional standard), if procreative potential exists.
• Adequate recovery from recent surgery, chemotherapy, and radiation therapy.
• Accessible for treatment and follow-up, must be treated at the participating center.

You may not qualify if…

• Received chemotherapy or therapeutic radiotherapy 28 days prior to the first dose of study medication or has ongoing side effects ≥ grade 2 due to agents administered more than 28 days earlier.
• 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 6 months prior to the first dose of study medication; uncontrolled hypertension; clinically significant cardiac arrhythmia including but not limited to: multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia; uncontrolled diabetes; psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
• Progressive or symptomatic brain metastases
• Has a serious or nonhealing active wound, ulcer, or bone fracture.
• Known human immunodeficiency virus positivity.
• Major surgical procedure, an open biopsy, or a significant traumatic injury 28 days prior to treatment.
• Is currently or has recently used (28 days prior to) a thrombolytic agent.
• Currently using 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). A patient requiring heparin is excluded.
• Undergoes chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function (cyclooxygenase-2 [COX-2] inhibitors are permitted).
• Has a history or clinical evidence of a deep venous or arterial thrombosis (including pulmonary embolism) 6 months prior to the first dose of study medication.
• Has proteinuria ≥ 2+ by routine urinalysis
• Pregnancy (confirmed by serum beta human chorionic gonadotropin) or lactating
• Received prior treatment with agents targeting the PDGFR ligand or receptor 6 weeks prior to the first dose of study medication.
• Received prior treatment with monoclonal antibodies 6 weeks prior to the first dose of study medication.
• Has a history of allergic reactions to monoclonal antibodies or other therapeutic proteins.

Where it is running

• ImClone Investigational Site — Indianapolis, Indiana, United States
• ImClone Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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