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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01288989
First received: January 31, 2011
Last updated: July 23, 2014
Last verified: July 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • Antitumor activity of single agent IMC-3C5 [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
  • Terminal half-life (t1/2) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Clearance (Cl) of IMC-3C5 [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
  • Anti-IMC-3C5 Antibody Assessment [ Time Frame: Up to Week 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288989

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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. Recruiting
Peoria, Illinois, United States, 61615
Contact: Eli Lilly         
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. Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Eli Lilly         
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. Recruiting
Boston, Massachusetts, United States, 02111
Contact: Eli Lilly         
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. Recruiting
New York, New York, United States, 10029
Contact: Eli Lilly         
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01288989     History of Changes
Other Study ID Numbers: 14247, CP23-1001, I5G-IE-JBCA
Study First Received: January 31, 2011
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors

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

ClinicalTrials.gov processed this record on August 01, 2014