Study on Crizotinib for Cancers with ROS1 Genetic Changes (MATCH-Subprotocol G)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439253
This clinical trial is testing the drug crizotinib to see if it can help shrink or stop the growth of cancers that have a specific genetic change called ROS1 translocation. The study aims to find out if crizotinib can effectively target and block a protein that may be helping cancer cells grow.
Patient Parameters
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Program Overview
The purpose of this phase II study is to see if crizotinib can help treat patients with advanced cancers that have a genetic change known as ROS1 translocation. Crizotinib works by blocking a protein called ROS1, which may be necessary for cancer cells to grow. Researchers want to know if this drug can shrink tumors or stop them from growing.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer size after taking crizotinib. Researchers also want to know how many patients are still alive and have not seen their cancer grow after six months of treatment. They will also look at how long it takes for the cancer to start growing again or for the patient to pass away.
Additionally, the study will explore other factors that might predict how well the treatment works, such as specific genetic markers or changes seen in imaging tests before and after treatment.
Participants in the study will take crizotinib by mouth twice a day in 28-day cycles. They will continue this treatment as long as it is effective and does not cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits every three months for the first two years, and then every six months in the third year.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria of the main MATCH study before joining this sub-study.
- Must have a genetic change involving the ROS1 gene, as confirmed by the main MATCH study.
- Must have a recent electrocardiogram (ECG) showing no significant heart rhythm or conduction issues.
Exclusion Criteria
- Cannot have non-small cell lung cancer (NSCLC) with ROS1 rearrangements.
- Cannot have a history of lung diseases like interstitial lung disease or pneumonitis.
- Cannot be allergic to crizotinib or similar drugs.
- Cannot be taking certain medications or foods that strongly affect liver enzymes (CYP3A4).
- Cannot have previously taken any ROS1 inhibitors, including crizotinib and other similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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