Enrollment complete
Phase II Study of Crizotinib in Patients with ROS1 Translocations (Other Than Patients with Non-Small Cell Lung Cancer) (MATCH Substudy)
NCT No.: NCT04439253
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: Colorado
Acronym:
Official Title
Phase II Study of Crizotinib in Patients with ROS1 Translocations (Other Than Patients with Non-Small Cell Lung Cancer) (MATCH Substudy)
Purpose
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.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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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)
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Exclusion Criteria
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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
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Keywords and/or Specific Medical Conditions
Sponsors
- National Cancer Institute (NCI)
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