Overview

Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)

Status:
Active, not recruiting
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ROS1 translocation. Crizotinib may block a protein called ROS1, which may be needed for cancer cell growth. Researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Crizotinib
Criteria
Inclusion Criteria:

- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
prior to registration to treatment subprotocol

- Patients must be positive for translocation or inversion events involving the ROS1
gene via the MATCH Master Protocol

- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
assignment and must have no clinically important abnormalities in rhythm, conduction
or morphology of resting ECG (e.g. complete left bundle branch block, third degree
heart block)

Exclusion Criteria:

- Patients must not have NSCLC with ROS1 rearrangements

- Patients with a history of interstitial lung disease or pneumonitis are excluded

- Patients must not have known hypersensitivity to crizotinib or compounds of similar
chemical or biologic composition

- Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will
be excluded

- Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib,
ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072,
KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922