Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within days prior to sub-study registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: () metastases have been locally treated and have remained clinically controlled and asymptomatic for at least days following treatment and prior to registration, AND () patient has no residual neurological dysfunction and has been off corticosteroids for at least hours prior to sub-study registration
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least weeks prior to enrollment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for days
Spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least weeks before first dose of study drug
Spinal cord compression or brain metastases unless asymptomatic treated and stable and not requiring steroids
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for days
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least weeks prior to start of study treatment
Subject with known active CNS metastasis, except primary brain tumors. Subjects with asymptomatic brain metastases or spinal cord compression who have been treated, are considered stable, and have not received steroid doses > mg/day of prednisolone equivalent to treat these conditions prior to consent may be included;
Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable for at least weeks prior to the first dose of study medication
Active or untreated brain metastases or spinal cord compression\r\n* A scan to confirm the absence of brain metastases is not required\r\n* Patients with treated brain metastases or spinal cord compression are eligible if they have minimal neurologic symptoms and evidence of stable disease (for at least month) or response on follow-up scan; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least days prior to treatment
Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least weeks prior to start of study treatment.
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for days
Has known brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids for at least days prior to start of study treatment); following radiotherapy and/or surgery of the brain metastases patients must wait weeks following the intervention and before initiating study treatment with imaging to confirm stability
Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a magnetic resonance imaging (MRI) (preferred) or CT each preferably with IV contrast of the brain prior to study entry or brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids and anti-convulsants for at least - days prior to start of study treatment). Following radiotherapy and/or surgery of the brain metastases patients must wait weeks following the intervention to confirm stability.
Brain metastases or spinal cord compression unless asymptomatic and not requiring steroids for at least days prior to start of study treatment
Patients with symptomatic uncontrolled brain metastases or spinal cord compressions. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least days prior to treatment.
Brain metastases or spinal cord compression are NOT permitted unless they have been treated with the patient's condition being stable clinically and radiologically for at least calendar days and off steroids for at least calendar days prior to the start of study treatment; patients with suspected or known brain metastases at screening should have a magnetic resonance imaging (MRI) (preferred) or CT brain/head, preferably with IV contrast, to assess baseline disease status
Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least days prior to study treatment start. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
Known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and/or radiation, and has been stable without requiring corticosteroids nor anticonvulsant medications for at least weeks prior to the first dose of study medication. Patients with history of brain metastases should undergo brain imaging within weeks of therapy initiation and at each restaging
Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and/or radiation, and has been stable without requiring escalating corticosteroids nor anti-convulsant medications for at least weeks prior to the first dose of study medication
Brain metastases or spinal cord compression, unless treatment was completed at least weeks before study entry, and stable without steroid treatment for at least weeks
Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least weeks prior to start of study treatment
Has a spinal cord compression unless asymptomatic, radiographically stable over the last weeks, and not requiring steroids for at least weeks before the start of study treatment
Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least months
Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for days or longer; Subjects requiring steroids within weeks prior to start of study treatment will be excluded;
Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status.
Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least days
Brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least weeks before starting protocol therapy and the condition has been stable without steroid treatment for at least days
Spinal cord compression unless asymptomatic and not requiring steroids for at least weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past years. Exceptions are
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least weeks prior to treatment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for days
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for days.
Subjects with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic.
Symptomatic brain or spinal cord metastases (patients must be stable for > month post radiotherapy or surgery).
Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study if these were started at least weeks prior to treatment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for days; patients with known uncontrolled brain metastases should be excluded from this clinical trial
Leptomeningeal or brain metastases or metastases causing spinal cord compression that are symptomatic or untreated or not stable for >= months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > month or who have been off of corticosteroids for at least weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > weeks
Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within days prior to Step re-registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: () metastases have been locally treated and have remained clinically controlled and asymptomatic for at least days following treatment and prior to re-registration, AND () patient has no residual neurological dysfunction and has been off corticosteroids for at least hours prior to re-registration
Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within days prior to Step Re-registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: () metastases have been locally treated and have remained clinically controlled and asymptomatic for at least days following treatment prior to re-registration, AND () patient has no residual neurological dysfunction and has been off corticosteroids for at least hours prior to re-registration
Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within days prior to step re-registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: () metastases have been locally treated and have remained clinically controlled and asymptomatic for at least days following treatment and prior to re-registration, AND () patient has no residual neurological dysfunction and has been off corticosteroids for at least hours prior to re-registration
DISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: () metastases have been locally treated (including stereotactic body radiation therapy [SBRT], whole brain radiotherapy [WBRT], and surgical resection) and have remained clinically controlled and asymptomatic for at least days following treatment and prior to registration, AND () patient has no residual neurological dysfunction and has been off corticosteroids for at least hours prior to registration
Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within days prior to RE-TREATMENT registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: metastases have been locally treated and have remained clinically controlled and asymptomatic for at least days following treatment and prior to RE-TREATMENT registration, AND patient has no residual neurological dysfunction and has been off corticosteroids for at least hours prior to RE-TREATMENT registration
Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least weeks prior to start of study treatment
Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; . History of leptomeningeal carcinomatosis; . Active or prior documented autoimmune or inflammatory disorders; . Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least days prior to study treatment start; . QT interval corrected for heart rate using Fridericia's formula (QTcF) ? ms; . Known allergy or hypersensitivity to IP or any IP excipient
Has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (CNS)
Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least weeks after completion of the definitive therapy and steroids.
Patients who have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids (except those prohibited per protocol) before/during study if these were started at least days prior to entry
Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
Unstable brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least weeks before starting treatment and the condition has been stable without steroid treatment for at least days
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least weeks prior to start of study treatment.
Presence of symptomatic or untreated leptomeningeal or spinal cord compression. Subjects who have been previously treated for these conditions and have stable CNS disease (documented by consecutive imaging studies) for > days, are asymptomatic and currently not taking corticosteroids, or have been on a stable dose of corticosteroids for at least days prior to enrollment, are permitted
Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms and steroid use (if applicable) have been stable for days prior to the first dose of LOXO-
Brain metastases or spinal cord compression, unless treated at least weeks before first dose and stable without steroid treatment for days
Patients with brain metastases or spinal cord compression unless they completed radiation therapy >= weeks prior to the first dose of ponatinib and are stable without steroids or anti-convulsant therapy for >= days
Patients may not have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids before/ during study if these were started at least days prior to entry
History of spinal cord compression or brain metastases, unless asymptomatic, treated, stable, and not requiring treatment with steroids for at least weeks before the planned administration of the first dose of study drug. Any history of leptomeningeal metastases.
Brain metastases or spinal cord compression, unless treatment was completed at least weeks before study entry, and stable without steroid treatment for at least weeks
Spinal cord compression or brain metastases unless asymptomatic and not requiring steroids for at least weeks
Symptomatic leptomeningeal or brain metastases or spinal cord compression Note: Subjects previously treated for these conditions are eligible if they meet both of the criteria below: () have had stable CNS disease for at least weeks after local therapy as assessed by imaging (contrast enhanced magnetic resonance imaging [MRI] or computed tomography [CT]) prior to Day , and () are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least weeks prior to Day .
Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids.
Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least days prior to study treatment start; patients with suspected brain metastases at screening should have a CT/magnetic resonance imaging (MRI) of the brain prior to study entry