Crizotinib in Patients with Tumors (other Than Adenocarcinoma of Lung or ALCL) with ALK Rearrangements (MATCH Substudy)
This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ALK rearrangement. Crizotinib may stop the growth of cancer cells by blocking the ALK protein which may be needed for cell growth. Researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.
|
Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol;
|
|
|
|
Patients must have an ALK rearrangement as defined 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)
|
|
Patients must not have non small cell lung cancer or anaplastic large cell lymphoma (ALCL);
|
|
|
|
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 must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922;
|
|
|
|
Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment
|