NCT00768391CompletedPhase 1
Phase I Study of Anti-Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Monoclonal Antibody IMC-3G3 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom no Standard Therapy is Available
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Summary of Participants Reporting Adverse Events
Study Overview
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 respond to standard therapy or for whom no standard therapy is available.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Summary of Participants Reporting Adverse Events
Time Frame: Approximately 36 months
Maximum Tolerated Dose (MTD)
Time Frame: Approximately 36 months
After all patients complete a cohort, toxicity data is reviewed before the next cohort of patients is treated at the next higher dose level
Secondary Outcomes
- Pharmacokinetics(6 weeks)
- Anti-IMC-3G3 Antibody Assessment(Approximately 36 months)
- Antitumor Activity of IMC-3G3 as Monotherapy(6 weeks)
- Pharmacodynamics(6 weeks)
Investigators
Study Sites (3)
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