A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

This study is currently recruiting participants.
Verified November 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01346358
First received: April 29, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.


Condition Intervention Phase
Neoplasms
Biological: IMC-CS4
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), 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:
  • Pharmacokinetics - Maximum concentration (Cmax) of IMC-CS4 [ Time Frame: Up to Week 36 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4 [ Time Frame: Up to Week 36 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4 [ Time Frame: Up to Week 36 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4 [ Time Frame: Up to Week 36 ] [ Designated as safety issue: No ]
  • Pharmacokinetics -Clearance (Cl) of IMC-CS4 [ Time Frame: Up to Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recommend Phase 2 Dose (RP2D) of IMC-CS4 [ Time Frame: Approximately 6 Months ] [ Designated as safety issue: No ]
  • Anti-IMC-CS4 Antibody Assessment [ Time Frame: Approximately 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-CS4
Patients receiving IMC-CS4 intravenously
Biological: IMC-CS4

Escalating doses of IMC-CS4 administered intravenously, weekly.

The starting dose will be 2.5 mg/kg weekly (Cohort 1).

Dose escalation will proceed to 0.3 mg/kg weekly (Cohort 2), 0.6 mg/kg weekly (Cohort 3), 1.25 mg/kg every two weeks (Cohort 4), 1.25 mg/kg weekly (Cohort 5), and 2.5 mg/kg weekly (Cohort 6).

Other Name: LY3022855

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has histologic or cytologic confirmation of advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
  • Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
  • Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subject has adequate hematologic, hepatic, renal, and coagulation function
  • Subject has a life expectancy greater than 3 months
  • Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy

Exclusion Criteria:

  • Subject has experienced acute pathologic fracture, spinal cord compression, or clinically significant hypercalcemia within 28 days prior to first dose of study therapy
  • Subject has a known hypersensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-CS4.
  • Subject has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
  • Subject has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
  • Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
  • Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder
  • Subject has known or suspected primary brain or leptomeningeal metastases
  • Subject has leukemia or lymphoma
  • Subject is know to have active tuberculosis, leishmaniasis, or listeriosis
  • Subjects with known history, or clinical or laboratory evidence of liver disease
  • Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
  • Subject if female, is pregnant or breastfeeding
  • Subject has received an organ transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346358

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, Ohio
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
Cleveland, Ohio, United States, 44106
Contact: Eli Lilly         
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
Columbus, Ohio, United States, 43210
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: NCT01346358     History of Changes
Other Study ID Numbers: 14311, CP24-1001, I5F-IE-JSCA
Study First Received: April 29, 2011
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014