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A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288989
First Posted: February 3, 2011
Last Update Posted: August 8, 2014
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.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Condition Intervention Phase
Neoplasms Biological: IMC-3C5 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Approximately 36 Months ]
  • Maximum tolerated dose (MTD) [ Time Frame: Approximately 36 Months ]

Secondary Outcome Measures:
  • Antitumor activity of single agent IMC-3C5 [ Time Frame: Approximately 36 Months ]
    Tumor response assessment will be done by computed tomography (CT) scan or Magnetic resonance imaging (MRI) every 6 or 8 weeks through out the study

  • Minimum concentration (Cmin) [ Time Frame: Up to Week 30 ]
  • Area Under the Curve (AUC) [ Time Frame: Up to Week 30 ]
  • Terminal half-life (t1/2) [ Time Frame: Up to Week 30 ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to Week 30 ]
  • Pharmacokinetics - Clearance (Cl) of IMC-3C5 [ Time Frame: Up to Week 30 ]
  • Anti-IMC-3C5 Antibody Assessment [ Time Frame: Up to Week 30 ]

Estimated Enrollment: 60
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-3C5
Patients receiving IMC-3C5 intravenously
Biological: IMC-3C5
Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week
Other Name: LY3022856

Detailed Description:

This multicenter study will enroll approximately 40 subjects. The actual sample size will vary depending on how many subjects are needed to obtain at least 3 complete subjects per cohort.

IMC-3C5 will initially be administered once every week (Cohorts 1-4) in a dose escalated manner. The starting dose will be 5mg/kg weekly (Cohort 1). Dose escalation will proceed to 10mg/kg (Cohort 2), 20 mg/kg (Cohort 3), and 30mg/kg (Cohort 4). Based on an analysis of the safety and pharmacokinetic profile of weekly dosing, subjects may be enrolled sequentially into 2 every-other-week dose cohorts (Cohorts 5-6, 20mg/kg and 30mg/kg). Intermediate doses may also be used.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subject has histologic or cytologic confirmation of cancer
  2. Subject has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
  3. Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
  4. Subject has not received prior chemotherapy or prior treatment with an investigational agent or device within 28 days prior to enrollment(hormone therapy is acceptable)
  5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
  6. Subject has adequate hematologic, hepatic, renal, and coagulation function
  7. Subject has a life expectancy greater than 3 months
  8. Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent

Exclusion Criteria:

  1. Subject has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5
  2. Subject has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment
  3. Subject has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
  4. Subject has an ongoing or active infection (except as outlined in Exclusion Criterion #11), congestive heart failure, active bleeding or any other serious uncontrolled medical disorder
  5. Subject has known or suspected untreated brain or leptomeningeal metastases
  6. Subject has uncontrolled hypertension
  7. Subject has received an organ transplant
  8. Subject has a serious or nonhealing wound, ulcer, or bone fracture
  9. Subject has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment
  10. Subject currently has peripheral edema requiring diuresis or anasarca
  11. Subject has Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), except subjects who have been on a stable antiviral regimen for at least 12 weeks, have a viral load of < 50 copies/mL, and a CD4 count of ≥ 200 cells/mm3
  12. Subject is currently using or has received a thrombolytic agent within 28 days prior to enrollment
  13. Subject is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation
  14. Subject if female, is pregnant or is lactating
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01288989


Locations
United States, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Peoria, Illinois, United States, 61615
United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston, Massachusetts, United States, 02111
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New York, New York, United States, 10029
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01288989     History of Changes
Other Study ID Numbers: 14247
CP23-1001 ( Other Identifier: ImClone Systems )
I5G-IE-JBCA ( Other Identifier: Eli Lilly and Company )
First Submitted: January 31, 2011
First Posted: February 3, 2011
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors

Additional relevant MeSH terms:
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs