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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by ImClone LLC:

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:	October 2013
Estimated Primary Completion Date:	October 2013 (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, California
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
San Francisco, California, United States, 94115-1710
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
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, 43210-1240

Sponsors and Collaborators

ImClone LLC

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)

ImClone LLC

More Information

No publications provided

Responsible Party:	ImClone LLC
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:	May 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by ImClone LLC:

Advanced Solid Tumors

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013