Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma
Status:
Terminated
Trial end date:
2018-07-25
Target enrollment:
Participant gender:
Summary
Background:
Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a
protein on the surface of tumor cells in many types of tumors, including most lung cancers.
Researchers want to find a safe dose for the study drug for lung cancer. They want to see if
it can shrink tumors in mesothelin-positive lung cancer.
Objectives:
To test the safety and effectiveness of anetumab ravtansine for lung cancer.
Eligibility:
Adults 18 years and older who have lung cancer that has gotten worse on other therapy
Design:
Participants will be screened with:
Medical history
Physical exam
Tumor tissue sample. This can be from a previous procedure.
Blood and urine tests
Heart tests
Scans. For one scan, a small amount of radioactive substance is injected into the blood.
Eye exam
The study will have 21-day cycles.
On day 1 of each cycle, participants will get the study drug through a tube inserted in a
vein.
Participants will repeat a heart test in cycles 1 and 2.
They will have blood tests weekly in cycle 1, twice in all other cycles.
They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of
year 2, then every 12 weeks.
Participants will have samples of tumor tissue taken twice.
About 30 days after stopping the study drug, participants will have a follow-up visit. This
will include medical history, physical exam, blood and pregnancy tests, and heart and eye
tests.
Some will be called a few times a year to discuss their health and treatment.