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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 3, 2014
Last verified: September 2014
  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: December 2015
Estimated Primary Completion Date: July 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
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: 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: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors

ClinicalTrials.gov processed this record on September 18, 2014