Study of IMC-1121B in Patients With Advanced Solid Tumors Not Responding To Standard Therapy
NCT00786383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2013-08-19
Summary
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study.
We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Conditions
Interventions
- BIOLOGICAL
-
IMC-1121B
Cohort 1 6 mg/kg I.V., once every other week for 4 weeks
- BIOLOGICAL
-
1121B
Cohort 2 8mg/kg I.V., once every other week for 4 weeks
- BIOLOGICAL
-
1121B
Cohort 3 10 mg/kg I.V., once every other week for 4 weeks
- BIOLOGICAL
-
1121B
Cohort 4 15 mg/kg I.V., once every 3 weeks for 6 weeks
- BIOLOGICAL
-
1121B
Cohort 5 20 mg/kg I.V., once every 3 weeks for 6 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
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
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-02-28
- Primary Completion
- 2009-01-31
- Completion
- 2009-01-31
Countries
- United States
Study Locations
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