Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics - Maximum concentration (Cmax) of IMC-CS4

Outcome Time Frame:

Up to Week 36

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14311

NCT ID:

NCT01346358

Start Date:

June 2011

Completion Date:

October 2013

Related Keywords:

  • Neoplasms
  • Advanced Solid Tumors
  • Neoplasms

Name

Location

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.Greenbrae, California  94904
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.Cincinnati, Ohio  45267