Status:
COMPLETED
Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available
Lead Sponsor:
Eli Lilly and Company
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-PDGFRα monoclonal antibody IMC-3G3 in patients with advanced solid tumors who no longer respon...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00768391
Start Date
December 1 2006
End Date
January 1 2010
Last Update
June 28 2011
Active Locations (2)
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1
ImClone Investigational Site
Indianapolis, Indiana, United States, 46282
2
ImClone Investigational Site
Houston, Texas, United States, 77030