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

NCT00768391 | Completed Phase 1

• 3 other identifiers: 13937CP15-0601I5B-IE-JGDC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumors

Keywords

Tumors; Lymphoma; Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (2)

• Summary of Participants Reporting Adverse Events

  Approximately 36 months

• Maximum Tolerated Dose (MTD)

  After all patients complete a cohort, toxicity data is reviewed before the next cohort of patients is treated at the next higher dose level

  Approximately 36 months

Secondary Outcomes (4)

• Pharmacokinetics

  6 weeks

• Anti-IMC-3G3 Antibody Assessment

  Approximately 36 months

• Antitumor Activity of IMC-3G3 as Monotherapy

  6 weeks

• Pharmacodynamics

  6 weeks

Study Arms (1)

IMC-3G3

EXPERIMENTAL

All patients will receive intravenous infusions of IMC-3G3, with the dose depending on which cohort they are enrolled into.

Biological: IMC-3G3

Interventions

IMC-3G3 BIOLOGICAL

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.

IMC-3G3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

ImClone Investigational Site

Indianapolis, Indiana, 46282, United States

Location

ImClone Investigational Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma

Interventions

olaratumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: January 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

US (2)