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Title:
9952 Phase 1 Trial to Determine the Recommended Phase 2 Dose (RP2D) of VX-970 When Combined with Whole Brain Radiotherapy (WBRT) in Patients with Brain Metastases from Non-Small Cell Lung Cancer (NSCLC)
Protocol Number:
ETCTN9952
Phase:
Phase I
Physician:
Jarushka Naidoo
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to test the safety of the study drug called VX-970 at different doses when given with standard whole brain radiation therapy (WBRT).
Eligibility:
Generally healthy adults with advanced non-small cell lung cancer (NSCLC) that has spread to the brain (brain metastases) and your doctor is recommending whole brain radiation therapy (WBRT) may be eligible.
Treatment:
Different doses of the study drug VX-970 will be given to several study participants. It will be given through a vein (intravenously) two times a week during the course of WBRT. Once WBRT finishes, patients will not be able to receive additional doses of the drug. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered. The study is stopped once the investigators have determined a safe dose.You will receive the study drug VX-970 given with WBRT for three weeks. After you finish VX-970 and WBRT, your doctor will continue to watch you for side effects and follow your condition for up to two years from the time of study entry. If you are removed from the study for unacceptable side effects, your doctor will continue to monitor you until resolution or stabilization of the side effects.
Population:
Adult
Last Update
03/05/2019 05:03 AM