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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768391
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : June 28, 2011
Information provided by:
ImClone LLC

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Biological: IMC-3G3 Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IMC-3G3
All patients will receive intravenous infusions of IMC-3G3, with the dose depending on which cohort they are enrolled into.
Biological: IMC-3G3
Intravenously, once every week for Cohorts 1 through 3 and once every other week for Cohorts 4 and 5. Starting dose will be 4mg/kg in Cohort 1, with dose doubling between cohorts. Dose escalation of 100% (2 x previous dose) Dose escalation increment reduced to 33% (1.33 x previous dose). Cohorts 4 and 5 will receive 15mg/kg and 20mg/kg, intravenously, once every other week.

Primary Outcome Measures :
  1. Summary of Participants Reporting Adverse Events [ Time Frame: Approximately 36 months ]
  2. 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 Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 6 weeks ]
  2. Anti-IMC-3G3 Antibody Assessment [ Time Frame: Approximately 36 months ]
  3. Antitumor Activity of IMC-3G3 as Monotherapy [ Time Frame: 6 weeks ]
  4. Pharmacodynamics [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry.
  3. Able to provide written informed consent.
  4. Age 18 years or older.
  5. Life expectancy of > 3 months.
  6. Adequate hematologic function, as defined by: an absolute neutrophil count ≥ 1500/mm3; a platelet count ≥ 100,000/mm3
  7. 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
  8. Adequate renal function, as defined by serum creatinine level ≤ 1.5 x the ULN.
  9. Uses effective contraception (per the institutional standard), if procreative potential exists.
  10. Adequate recovery from recent surgery, chemotherapy, and radiation therapy.
  11. Accessible for treatment and follow-up, must be treated at the participating center.

Exclusion Criteria:

  1. 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.
  2. 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
  3. Progressive or symptomatic brain metastases
  4. Has a serious or nonhealing active wound, ulcer, or bone fracture.
  5. Known human immunodeficiency virus positivity.
  6. Major surgical procedure, an open biopsy, or a significant traumatic injury 28 days prior to treatment.
  7. Is currently or has recently used (28 days prior to) a thrombolytic agent.
  8. 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.
  9. 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).
  10. 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.
  11. Has proteinuria ≥ 2+ by routine urinalysis
  12. Pregnancy (confirmed by serum beta human chorionic gonadotropin) or lactating
  13. Received prior treatment with agents targeting the PDGFR ligand or receptor 6 weeks prior to the first dose of study medication.
  14. Received prior treatment with monoclonal antibodies 6 weeks prior to the first dose of study medication.
  15. Has a history of allergic reactions to monoclonal antibodies or other therapeutic proteins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768391

United States, Indiana
ImClone Investigational Site
Indianapolis, Indiana, United States, 46282
United States, Texas
ImClone Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
ImClone LLC
Study Director: E-mail: ClinicalTrials@ ImClone LLC

Responsible Party: Chief Medical Officer, ImClone LLC Identifier: NCT00768391     History of Changes
Other Study ID Numbers: 13937
CP15-0601 ( Other Identifier: ImClone, LLC )
I5B-IE-JGDC ( Other Identifier: Eli Lilly and Company )
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by ImClone LLC:
Antibodies, Monoclonal