Brain metastases
At least 1 measurable unirradiated parenchymal brain metastasis within 21 days prior to study entry; patients who are to undergo SRS must have no more than 10 brain metastases; there is no limit on number of brain metastases for WBRT; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:\r\n* For a single solitary lesion the size must be >= 10 mm\r\n* For 2 or more lesions, the size of at least 2 of the lesions must be >= 5 mm\r\n* Patients may also have the following provided the size requirements above are met:\r\n** Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion\r\n** Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion
No active brain metastases
Patients with untreated brain metastases. Patients with treated brain metastases who are off corticosteroids for at least two weeks and who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
Uncontrolled brain metastases
Females who are pregnant or breastfeeding. ? Patients who have active or stable brain metastases or who have a history of brain metastases.
Subjects with brain metastases
Any current brain or subdural metastases
Active brain metastases
Some types of brain metastases
Patients may not have diagnosed brain metastases
Brain metastases (brain imaging is not required)
Patients with uncontrolled brain metastases.
Uncontrolled brain metastases
Brain metastases.
Known brain metastases
Patients with metastases
Brain metastases that:
Known brain metastases
Recurrent brain metastases
Patients with known brain metastases
Patients with 1-10 untreated brain metastases at time of initial brain metastases diagnosis (surgery to one of the brain lesions and/or biopsy of a lesion for diagnostic purposes and/or for standard of care purposes is acceptable)
Subjects with brain metastases are eligible
Known brain metastases
The presence of known brain metastases
Patient has known brain metastases,
Patients with known brain metastases
Presence or history of brain metastases.
History of brain metastases
History of prior brain metastases
Patients who have metastases to the brain.
The patient has active brain metastases
History of, or current brain metastases
Known brain metastases who are clinically unstable
Patients must have a history of brain metastases that are non-progressing.
Patients with a prior history of brain metastases are eligible provided:\r\n* The brain metastases have been treated\r\n* The patient is asymptomatic from the brain metastases\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration\r\n* The brain metastases are stable on pre-registration imaging
Metastases in the brain
Subjects with active brain metastases.
Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
Patient does not have any brain metastases in the genu
Patients with brain metastases in the genu
If history of brain metastases must be stable for at least 3 months after treatment – a brain computed tomography (CT) scan or MRI is only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases
Presence or history of brain metastases
Brain metastases or a history of brain metastases
Metastases to brain per prior clinical evaluation;
Subjects with brain metastases
Patient with a known history or evidence of brain metastases
Patients with uncontrolled brain metastases; patients with brain metastases must be asymptomatic and off corticosteroids for at least one week
Patients with active brain metastases; a scan to confirm the absence of brain metastases is not required for asymptomatic patients
Patients with known brain metastases
Known brain metastases
Greater than 10 brain metastases; excluding previously treated and stable brain metastases
Patients with brain metastases.
History or evidence of brain metastases
Patients with known brain metastases
Patient must have 10 or less brain metastases
Brain metastases meeting either of the following exclusion criteria:\r\n* Untreated brain metastases\r\n* After completion of brain-directed therapy, the patient has not been able to tolerate discontinuation of steroids or a decrease in steroid dose
The patient has symptomatic brain metastases; asymptomatic brain metastases are permitted provided that there is no steroid requirement, no more than 4 metastases detected on standard MRI imaging, no metastatic brain lesion that is > 3 cm in size, and no lepto-meningeal disease
Known brain metastases
More than four additional diagnosed brain metastases
Patients with known brain metastases
Patients must have 1-5 brain metastases total
Current symptomatic brain metastases; if previously present, the metastases must have been treated at least two months before participation in this study; CT or MRI scan of the brain is mandatory to assess the presence or not of brain metastases
Gliomas are excluded, as well as any history of brain metastases, seizures or underlying brain injury
Presence of brain metastases
Patients with uncontrolled brain metastases; patients with brain metastases must be asymptomatic and off corticosteroids for at least one week
Symptomatic brain metastases; patients with known brain metastases are eligible if the metastases are asymptomatic and previously treated
Must not have known brain metastases
Patients with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 4 weeks after completion of local therapy
Patients with untreated brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases; patients with brain metastases that have been definitively treated and on stable or decreasing dose of steroid within 4 weeks of starting study treatment will be eligible
Symptomatic brain metastases; patients with known brain metastases are allowed if they are asymptomatic
Presence of brain metastases
Patient with a known history or evidence of brain metastases
History of brain metastases within the last four years
Subjects with known brain metastases.
Patients with brain metastases (except as allowed in section 4.1.14 of the protocol. Neurological assessment will be used to determine brain metastases.
Patient with active brain metastases are not eligible. Patients with treated brain metastases are eligible if :
Known brain metastases
Either no brain metastases or irradiated stable brain metastases
Symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 14 days) or brain metastases that have not been previously treated
Documented primary brain malignancy or brain metastases
Known brain metastases (even if treated)
Active brain metastases
Patients with known brain metastases
Patients with brain metastases
Patients with known brain metastases should be excluded from this clinical trial; no additional workup is needed to exclude brain metastases if the patient is asymptomatic or has no history of brain metastases
Known brain metastases, except brain metastases that have been previously removed or irradiated and currently have no clinical impact
If history of brain metastases must be stable for at least 3 months after treatment-a brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases
Active brain metastases; patients with treated and stable (for at least 4 weeks) brain metastases are eligible; brain metastases will not be considered measurable lesions for the purpose of this trial
Subjects with known brain metastases
Primary brain tumors or active brain metastases
Patients with brain metastases (including treated or stable brain metastases)
Patients must not have active brain metastases from a systemic solid tumor
Brain metastases or a history of brain metastases
Patients with known brain metastases
Subjects with known brain metastases
Patients with known brain metastases
NSCLC subjects with known brain metastases (certain exceptions allowed)
Gastric adenocarcinoma subjects with brain metastases
All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
Brain metastases considered unstable as:
Patients with untreated brain metastases are allowed provided that the patient is clinically asymptomatic and stable; patients with a prior history of symptomatic brain metastases are eligible provided:\r\n* The brain metastases have been treated\r\n* The patient is asymptomatic from the brain metastases at enrollment\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration\r\n* The brain metastases are stable on pre-registration imaging
Known brain metastases
Presence of or known history of brain/CNS tumor or metastases
History of brain metastases that meet certain conditions;
Brain metastases considered unstable as:
Have known brain metastases.
Patients must not have history of brain metastases
No known brain metastases
Known brain metastases
Have known brain metastases.
Presence of brain metastases
Cancer metastases in the brain
Patients with known brain metastases
Presence of brain or subdural metastases
Known metastases to the brain
Documented brain metastases
Subject has known brain metastases
Known brain metastases
Any history of or current brain or subdural metastases
Patients must not have known brain metastases because the study drug has not been adequately tested in this setting
Has known brain metastases
There is no limit on the number of brain metastases
Symptomatic brain metastases; known brain metastases are allowed if asymptomatic and previously treated
Known brain metastases
Known brain metastases
Known brain metastases
Patient has a known history or evidence of brain metastases
One or more brain metastases
Known brain metastases
Patients with known brain metastases
Known brain metastases;
Active brain metastases or unevaluated neurologic symptoms suggestive of brain metastases; subjects with brain metastasis and documented stable disease for > 6 weeks may be included in this study; brain metastases will not be considered measurable lesions for the purposes of this trial
History or evidence of brain metastases
Patients with known brain metastases are NOT eligible for participation
Patients with known brain metastases
Documented and ongoing brain metastases
Documented brain metastases
Patients with evidence upon physical examination of brain tumor and any brain metastases
Active brain metastases
Known brain metastases
No more than 4 brain metastases
Subjects with known brain metastases and/or unresectable sarcoma
Uncontrolled brain metastases and infections; patients with brain metastases treated with gamma knife (GK) or whole brain radiation within 24 hours of registration
Subjects with brain metastases are excluded if their brain metastases are:
Active seizure disorder or evidence of brain metastases; (appropriate imaging should be done to rule out brain metastases)
Known brain metastases
Known or suspected brain metastases
Patients with hemorrhagic brain metastases
Patients with brain metastases
Previously documented or current brain metastases.
Known brain metastases
Brain metastases
Brain metastases
Active brain metastases.
Known brain metastases.
Subject has known brain metastases.
Subjects with leptomeningeal metastases may or may not have brain metastases. When brain metastases are present, they do not need to have progressed after radiation therapy
Clinically active brain metastases
Patients with known brain metastases should have their brain metastases treated prior to enrollment on this protocol; subjects may enroll on this trial after completion of whole brain radiation therapy and/or stereotactic radiosurgery, provided they are clinically without evidence of progressive brain metastases
Subjects with known or suspected brain metastases, primary brain tumors, or brain as the only site of disease
History or clinical evidence of brain metastases
Patients with known brain metastases
Patients with a prior history of brain metastases are eligible provided:\r\n* The brain metastases have been treated\r\n* The patient is asymptomatic from the brain metastases\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration
Presence of symptomatic or uncontrolled brain or central nervous system metastases. Patients with stable, treated brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
Patients with known brain metastases
Documented primary brain malignancy or brain metastases.
Subject has known brain metastases
Recurrent brain metastases from breast cancer
Brain metastases
Documented metastases to brain or meninges.
Active brain or subdural metastases
Active or progressing brain metastases
Known brain metastases
Known brain metastases (systematic screening of patients not mandatory)
The patient has a primary brain tumor. Patients may have brain metastases from another primary site.
Patients with known brain metastases
Active or progressing brain metastases
Patients with known uncontrolled brain metastases are excluded; however, patients with stable brain disease (off corticosteroids) at least 2 weeks after completion of appropriate therapy for their brain metastases are eligible
Active brain metastases
Patient must not have known active brain metastases; patients with previously treated brain metastases are eligible; patients with known brain active metastases must be excluded from this clinical trial
Patients with known brain metastases
Uncontrolled brain metastases
Known or suspected metastases in the brain
Presence of brain metastases
Known history or evidence of brain metastases
Subjects with brain metastases
First presentation of brain metastases
Subjects may have distant metastasis, including brain metastases. Subjects with known brain metastases are eligible if:
Known brain metastases (scan required at screening)
Patients with brain metastases are excluded
Uncontrolled brain metastases; patients with brain metastases are permitted if they have received appropriate therapy and demonstrated control of the brain metastases following therapy; patients with known brain metastases will require magnetic resonance imaging (MRI) brain to demonstrate disease control prior to enrollment (lack of symptom progression for two weeks off therapeutic doses of steroids, excluding chronic steroids used for control of chronic obstructive pulmonary disease [COPD])
Known brain metastases
Patient has a condition that may have affected the permeability of the blood-brain barrier (e.g., known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy)
Patients with known brain metastases;
Presence of brain metastases
Metastases to the brain
Metastases to the brain
Participant had breast cancer with brain metastases
Metastases to the brain
Patients with known brain metastases, history of brain metastases or radiation to the brain.
Patients with a prior history of brain metastases are eligible provided:\r\n* The brain metastases have been treated \r\n* The patient is asymptomatic from the brain metastases\r\n* Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration \r\n* The brain metastases are stable on pre-registration imaging
Known brain metastases
Known history of brain metastases
Evidence for hemorrhage within any of the brain metastases.
Brain metastases
Subject has known history of brain metastases.
Patients must have been diagnosed with one of the following:\r\n* Primary brain tumor (glioma, glioblastoma [GBM] etc); or\r\n* Up to 10 brain metastases
Known brain metastases
Known brain metastases
Active or progressing brain metastases
Patients with known brain metastases
Brain metastases have been treated.
History of leptomeningeal disease
Patient must not have leptomeningeal disease
Leptomeningeal disease
Leptomeningeal disease
Leptomeningeal disease as the only manifestation of the current malignancy
Multifocal disease or leptomeningeal disease (LM) disease on post-operative MRI;
History of leptomeningeal disease;
History of leptomeningeal metastatic disease
Leptomeningeal disease
Leptomeningeal involvement of cancer
Leptomeningeal disease
Patients with leptomeningeal disease are not eligible for participation\r\n* Please note: leptomeningeal enhancement is not an exclusion
Leptomeningeal disease
Known leptomeningeal disease
Known leptomeningeal or brainstem metastases (defined as positive CSF cytology and/or unequivocal radiological evidence of clinically significant leptomeningeal involvement; CSF sampling is not required in the absence of suggestive symptoms to exclude leptomeningeal involvement)
Participants with widespread, definitive leptomeningeal disease
Participants with widespread, definitive leptomeningeal disease
Leptomeningeal disease
Patients with leptomeningeal disease
Patients with metastatic disease, including leptomeningeal or subarachnoid disseminated disease.
Leptomeningeal disease
Has evidence of leptomeningeal disease
Patient has leptomeningeal disease
History of leptomeningeal disease
Diffuse leptomeningeal gliomatosis
History of leptomeningeal disease
Untreated CNS or leptomeningeal metastasis\r\n* Note: CNS or leptomeningeal disease must be stable for >= 3 months prior to registration
Patients with asymptomatic leptomeningeal disease are eligible for participation in this trial; however, patients who had progression of leptomeningeal disease on alectinib will be required to undergo CNS radiation to meet eligibility
Patients with known leptomeningeal metastatic disease
Patients with leptomeningeal disease
Leptomeningeal disease
Symptomatic or untreated leptomeningeal disease
Leptomeningeal disease
Patients with metastatic disease, including leptomeningeal or subarachnoid disseminated disease
Has presence of diffuse leptomeningeal disease or extracranial disease
Leptomeningeal involvement regardless of treatment status
Leptomeningeal involvement regardless of treatment status
Leptomeningeal disease
Evidence of leptomeningeal disease
Subjects with leptomeningeal disease are excluded
Presence of leptomeningeal disease
Diagnosis of leptomeningeal disease
Evidence of leptomeningeal spread of disease
Presence of leptomeningeal disease
Presence of extracranial metastatic or leptomeningeal disease
Leptomeningeal disease
Leptomeningeal disease
Presence of leptomeningeal disease
Presence of diffuse leptomeningeal disease
Imaging or cytologic evidence of leptomeningeal disease
Patients with multifocal disease or leptomeningeal disease who require whole brain radiotherapy (WBRT)
Presence of leptomeningeal disease
Known leptomeningeal involvement.
Leptomeningeal disease
Patients who have leptomeningeal disease
Patients with leptomeningeal disease
Symptomatic or untreated leptomeningeal disease.
History of leptomeningeal disease
Has infratentorial, or leptomeningeal evidence of recurrent disease
Leptomeningeal disease
Evidence of leptomeningeal dissemination
Patients with documented evidence of leptomeningeal disease
Leptomeningeal disease
Leptomeningeal disease.
Leptomeningeal disease
Leptomeningeal disease
History of leptomeningeal disease
History of leptomeningeal disease
Leptomeningeal disease
Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed)
Leptomeningeal disease
Has infratentorial, or leptomeningeal evidence of recurrent disease
Leptomeningeal disease
Has presence of diffuse leptomeningeal disease or extracranial disease
Leptomeningeal disease
Known leptomeningeal disease
Leptomeningeal disease
Presence of extracranial metastatic or leptomeningeal disease
Leptomeningeal disease
Patients with leptomeningeal disease are excluded
presence of Alzheimer's disease, meningioma, leptomeningeal disease from prostate cancer.
History of leptomeningeal disease
Patients with leptomeningeal disease are not eligible for participation
Patients with leptomeningeal disease
Infratentorial, or leptomeningeal evidence of recurrent disease
Symptomatic or untreated leptomeningeal disease
Patients with leptomeningeal disease
Multifocal disease or leptomeningeal spread
Evidence of leptomeningeal spread of glibolastoma or gliosarcoma.
Leptomeningeal disease as a manifestation of cancer
Leptomeningeal disease
Leptomeningeal disease as a manifestation of cancer
Any history of leptomeningeal disease
Leptomeningeal disease
History of leptomeningeal disease.
Symptomatic or untreated leptomeningeal disease
Leptomeningeal disease
Leptomeningeal disease as a manifestation of cancer
Leptomeningeal disease as a manifestation of cancer
Leptomeningeal disease
Leptomeningeal disease as the only manifestation of the current malignancy
Leptomeningeal disease
Leptomeningeal disease as the only manifestation of the current malignancy
Evidence of leptomeningeal spread of disease.
The participant has leptomeningeal disease.
Leptomeningeal disease as the only manifestation of the current malignancy
Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
History of leptomeningeal disease
Leptomeningeal disease
Leptomeningeal disease
Diffuse leptomeningeal disease at recurrence
Leptomeningeal disease
Leptomeningeal disease
Patients with carcinomatous meningitis should also be excluded
Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible
Has known carcinomatous meningitis
Known carcinomatous meningitis
Carcinomatous meningitis, as defined by positive cytology
COHORT C: Carcinomatous meningitis, as defined by positive cytology
History of carcinomatous meningitis
Subjects with carcinomatous meningitis
History of carcinomatous meningitis
Untreated or actively progressing CNS lesions (carcinomatous meningitis)
Presence or history of carcinomatous meningitis
Carcinomatous meningitis
Carcinomatous meningitis
Subjects with carcinomatous meningitis
Participants must not have carcinomatous meningitis
Subjects with carcinomatous meningitis.
Participants with carcinomatous meningitis
Patients with carcinomatous meningitis
Has known carcinomatous meningitis (also known as leptomeningeal disease)
CAPMATINIB EXCLUSION CRITERIA: Presence or history of carcinomatous meningitis
CERITINIB EXCLUSION CRITERIA: History of carcinomatous meningitis
History of carcinomatous meningitis
History of carcinomatous meningitis
Has carcinomatous meningitis;
Carcinomatous meningitis
Patients with carcinomatous meningitis should also be excluded
Subjects with carcinomatous meningitis
Known active brain metastases and/or carcinomatous meningitis
Subjects with carcinomatous meningitis
Subjects with carcinomatous meningitis
Has known carcinomatous meningitis, extracranial disease, or multifocal disease
Has known brain metastases and/or carcinomatous meningitis
Clinical evidence of brain metastases or carcinomatous meningitis
Subjects with carcinomatous meningitis
Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
Subjects with carcinomatous meningitis
Participants with carcinomatous meningitis
Leptomeningeal disease or carcinomatous meningitis
Carcinomatous meningitis
Carcinomatous meningitis
Presence of carcinomatous meningitis.
History of or known carcinomatous meningitis
Patients with carcinomatous meningitis
Patients with documented or suspected Candida meningitis.
Carcinomatous meningitis.
Known carcinomatous meningitis
Carcinomatous meningitis or leptomeningeal disease
History of carcinomatous meningitis.
Known or suspected brain metastasis or active leptomeningeal disease
Brain metastasis and/or leptomeningeal disease (known or suspected)
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or active leptomeningeal disease.
Patients with known or suspected brain metastasis
Subjects with known or suspected brain metastasis, or brain as the only site of disease are excluded with the following exceptions
Patients with known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or active leptomeningeal disease
For Cohort C:Has known or suspected brain metastasis or leptomeningeal carcinomatosis
Known or suspected brain metastasis or active leptomeningeal disease;
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Known or suspected brain metastasis or active leptomeningeal disease;
Known or suspected brain metastasis
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Known or suspected brain metastasis or active leptomeningeal disease
Suspected or known CNS metastasis
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or leptomeningeal disease.
Known or suspected brain metastasis;
Known or suspected brain metastasis or active leptomeningeal disease
Known or suspected brain metastasis or leptomeningeal disease
Active known or suspected brain metastasis or active leptomeningeal disease needing treatment
Active known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment.
Symptomatic brain metastasis or leptomeningeal disease
Cytologic or unequivocal radiographic confirmation of leptomeningeal metastasis by dural puncture and/or neuroimaging with or without known brain metastasis
Or any history of leptomeningeal metastasis.
Presence of brain metastasis or leptomeningeal spread of the disease
Patients with leptomeningeal metastasis.
Patients with a history of brain/leptomeningeal metastasis
Leptomeningeal disease or uncontrolled brain metastasis
Known brain metastasis or leptomeningeal involvement
Patients with leptomeningeal metastasis
Leptomeningeal metastasis
Active brain or leptomeningeal metastasis.
History or presence of brain metastasis or leptomeningeal disease
Leptomeningeal metastasis
Known brain metastasis or leptomeningeal disease
Known brain metastasis or leptomeningeal disease
Unstable or untreated brain/leptomeningeal metastasis
Current or previously treated brain metastasis or active leptomeningeal disease;
History of brain metastasis, active leptomeningeal disease or seizure
Patients with a history of brain/leptomeningeal metastasis
Active brain metastasis or leptomeningeal metastasis
Widespread definitive leptomeningeal metastasis
Any history of leptomeningeal metastasis.
Known brain metastasis or leptomeningeal disease
Any presence of leptomeningeal disease or any parenchymal brain metastasis
Leptomeningeal metastasis.
Brain metastasis, leptomeningeal disease.
The participant has symptomatic brain or leptomeningeal metastasis.
The participant has symptomatic brain or leptomeningeal metastasis.
Subject has current central nervous system (CNS) or leptomeningeal metastases or history of CNS or leptomeningeal metastases.
Leptomeningeal metastases
Leptomeningeal metastases
Known leptomeningeal or brainstem metastases. The presence of leptomeningeal enhancement alone, without associated clinical manifestations and/or positive CSF cytology, will not be constituted as known leptomeningeal metastases
Active brain metastases or leptomeningeal metastases
Leptomeningeal metastases
Metastases detected below the tentorium or beyond the cranial vault, including tumors with evidence of leptomeningeal metastases as previously indicated;
Presence of leptomeningeal metastases
Diffuse Leptomeningeal metastases with radiographic involvement in the brain and/or spinal cord. This does not include local leptomeningeal involvement which is defined as leptomeningeal enhancement within direct contact of targetable metastases
Participants must not have active brain metastases or leptomeningeal metastases
Subjects with leptomeningeal metastases in lumbar area.
History of leptomeningeal metastases
Active leptomeningeal metastases
Patients with leptomeningeal metastases
Leptomeningeal metastases
Must not have leptomeningeal metastases.
Leptomeningeal metastases
Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.
For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.
Evidence of leptomeningeal metastases
Participant has known leptomeningeal metastases.
Patients with active brain metastases or leptomeningeal metastases
Evidence of leptomeningeal metastases
Active brain metastases or leptomeningeal metastases are not allowed.
Active CNS metastases or leptomeningeal disease.
Active brain metastases or leptomeningeal metastases
Active brain metastases or leptomeningeal metastases
CNS metastases or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
Subjects with active brain metastases or leptomeningeal metastases
Patients with known or suspected leptomeningeal metastases.
Known leptomeningeal metastases not amenable to radiotherapy; patients receiving radiotherapy for leptomeningeal metastases are eligible
Brain metastases, leptomeningeal disease or bone metastases
Known leptomeningeal metastases
Active brain metastases or leptomeningeal metastases are not allowed
History of leptomeningeal metastases
Leptomeningeal metastases or brain metastases except as for Inclusion Criterion #6.
Active brain metastases or leptomeningeal metastases
Active metastases.
Those with leptomeningeal metastases as the only site of CNS disease
Patients with leptomeningeal metastases
Symptomatic CNS metastases or evidence of leptomeningeal disease.
Active metastases.
Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
Active brain metastases or leptomeningeal metastases
Presence of leptomeningeal disease or dural metastases.
Leptomeningeal metastases, hemorrhagic metastases, presence of midline shift; please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (magnetic resonance imaging [MRI] spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain
Evidence of CNS or leptomeningeal metastases
History of leptomeningeal metastases
Leptomeningeal metastases
Leptomeningeal metastases
Subjects with active brain metastases or leptomeningeal metastases
Patients with definitive leptomeningeal metastases
Leptomeningeal metastases; please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain
History of leptomeningeal metastases
Has active brain metastases or leptomeningeal metastases.