Patients must be able to undergo MRI of the brain with gadolinium; patients must be maintained on a stable or decreasing dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI
Stable dose of corticosteroids for at least 7 days
If patients are on corticosteroids, they must have been on a stable or decreasing dose >= 5 days prior to obtaining their baseline gadolinium (Gd)-magnetic resonance imaging (MRI) of brain; this MRI is to be obtained within 28 days of registration; NOTE: If patient needs escalation of steroids prior to therapy, or are on unstable doses of steroids they are not eligible
For subjects on corticosteroids for endocrine deficiencies or tumor-associated symptoms, must be on a stable (or decreasing) dose for at least 7 days before first dose of study treatment.
Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm per dimension on MRI performed within 14 days prior to registration; if receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI
Patients receiving unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms other than CNS related, dose must have been stabilized (or decreasing) for at least 5 days before first dose of INC280
Patients enrolling in the medical arm (Arms C and D) must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline MRI;
Phase I patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
Stable disease (SD) for >=30 days, without steroid use (or stable steroid dose established for >=14 days before the first dose of TAK-931).
To document the degree of tumor at study baseline, the following scan(s) must be obtained: • A brain MRI with and without contrast (ie, gadolinium) and a spine MRI with contrast within 21 days prior to first dose of study treatment. For subjects on steroids, baseline MRI scans must be performed while on stable or decreasing dose of steroids for at least 5 days.
Participants receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration.
Patients must be on a stable or decreasing dose of corticosteroids within 5 days prior to CT scan or MRI (which is done to determine eligibility); patients must be on no more than 8 mg a day but an attempt should be made to keep the dose at 4 mg or less; please contact the PI if doses of > 4 mg are needed
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for >1 month , are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/they are stable. This criterion does not apply to subjects with GBM cohort. In Part 1, subjects with GBM may enroll provided that they are on a stable to decreasing dose of corticosteroids for at least 14 days prior to the first dose of GSK3326595. In Part 2, subjects with GBM may enroll irrespective of steroid dose.
If receiving corticosteroids, patients must be on a stable or decreasing dose of corticosteroids for ? 5 days prior to baseline MRI.
CAPMATINIB EXCLUSION CRITERIA: Patients on unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms other than CNS related, dose must have been stabilized or decreasing for at least 5 days before first dose of capmatinib
For subjects on corticosteroids, they must be on a stable dose for 7 days prior to anticipated start of study drug
If receiving eltrombopag or romiplostim, the dose must have been stable for ? 21 days prior to the first dose of PRTX-100
If on steroid-sparing adjunctive immunosuppression with cyclosporine, azathioprine, mycophenolate, or 6-mercaptopurine, the dose must have been stable for ? 30 days prior to the first dose of PRTX-100 and must be expected to remain stable through study Day 29, unless dose reduction is required due to toxicities. Treatment with other cytotoxic agents (e.g. cyclophosphamide, vincristine) are not allowed within three months prior to the first dose of PRTX- 100.
Patients must be on stable dose of steroids for at least 5 days prior to baseline imaging
Have brain metastases that are neurologically unstable or require an increasing dose of corticosteroids. Patients must be on a stable or decreasing dose of corticosteroids for 7 days prior to first dose of AP32788.
If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
Corticosteroids: Participants receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to study drug administration (except when indicated for Central Nervous System [CNS] metastases, then participants must not have received corticosteroids for at least 28 days)
Stable dose of corticosteroids for CNS metastasis for > 7 days
Stable or decreasing dose of steroids for at least 5 days at the time of baseline brain MRI.
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the baseline MRI
Baseline MRI within 17 days of Day 1 & on steroid dosage that has been stable or decreasing for at least 5 days
Patients must be able to undergo MRI of the brain with gadolinium; patients must be maintained on a stable or decreasing dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI
If corticosteroids are required for controlling cerebral edema, patients must be on a stable dose of at least 1 week prior to enrollment
Solid tumor patients must be off corticosteroids prior to registration; if GBM patient is receiving corticosteroids, patient must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline magnetic resonance imaging (MRI) or computed tomography (CT); if steroids are added or the steroids dose is increased between the date of the screening MRI or CT and the start of treatment, a new baseline MRI or CT is required
Stable systemic disease
Co-medication that may interfere with study results, e.g., immuno-suppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the Investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to first dose of MRZ.)
Other ongoing anti-myeloma therapy. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to patient registration.
Neurologically stable defined as receiving no, stable, or tapering doses of corticosteroids for >= 5 days prior to drug dosing; treatment with corticosteroids during the study is allowed, and can be adjusted by the investigator during the study; changes in steroid dose are incorporated into the Revised Assessment in Neuro-Oncology (RANO) imaging criteria
If receiving corticosteroids, patients must be on a stable or decreasing dose of corticosteroids for ? 5 days prior to baseline MRI.
Patients must be on a stable or decreasing dose of corticosteroids for a minimum of 5 days before the baseline MRI/CT; if the corticosteroid dose is increased between the date of imaging and the initiation of study treatment, a new baseline MRI/CT is required; definition of stable steroids includes patients on no steroids
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Presence of brain metastases (except for subjects in the WHO Grade 1 or 2 or 3 or 4 glioma histology cohorts) that are symptomatic or untreated or not stable for >=3 months (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids >14 days and have not required treatment with enzyme-inducing anticonvulsants for >30 days prior to enrollment can be enrolled with approval of the Medical Monitor
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 >60 days, are asymptomatic and currently not taking corticosteroids, or have been on a stable dose of corticosteroids for at least 30 days prior to enrollment, are permitted
Patients must have been on a stable dose of corticosteroids >= 5 days prior to obtaining their baseline gadolinium (Gd)-MRI of brain
Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging
Patients must be on a stable or decreasing dexamethasone dosage for at least 1 week prior to baseline MRI
Steroids: patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to baseline MRI
The baseline on-study MRI should be performed within 14 days (+ 3 working days) prior to registration and on a steroid dosage that has been stable or decreasing for at least 5 days. If the steroid dose is increased between the date of imaging and the initiation of therapy (or at that time), a new baseline MRI is required. The same type of scan, i.e., MRI, must be used throughout the period of protocol treatment for tumor measurement.
Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, & on steroid dosage that has been stable or decreasing for at least 5 days
Patients can be on steroids as long as the dose has been stable for >= 7 days
Patients receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms, dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment.
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Patients must be on a steroid dose that has been stable or decreasing for at least 5 days; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required
If the steroid dose is increased between the date of the MRI and registration on the trial, a new baseline MRI is required; this MRI must be performed after >= 5 days on a stable dose of steroids
Unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non-CNS), dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment\r\n* Topical and inhaled steroids are allowed
Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI
Stable dose of corticosteroids for 2 weeks prior to enrollment
For patients on higher than physiological level of corticosteroids, they must have been on a stable dose for 1 week prior to initiating study drug, and the dose should not be escalated over entry dose level, if clinically possible
Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids