[c09aa8]: / clusters / 9knumclustersv2 / clust_2391.txt

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All Cohorts
Prior anti-PD- treatment for combination dose expansion cohorts a - d
Prior anti-PD- treatment for combination dose expansion cohorts e - h
Patients in expansion cohorts A and B must have measurable disease
EXPANSION COHORTS ONLY
For cohorts B and B only, biopsy confirmation of metastases (if safe and feasible at treating center)
DISEASE SPECIFIC EXPANSION COHORTS: Prior receipt of docetaxel is not permitted
For the expansion cohorts only: prior treatment with any MEK inhibitor is not allowed in the expansion cohorts
Have measurable disease based on:\r\n* Lugano classification (cohorts A, C)\r\n* International Workshop on CLL (cohorts B, D)
(For both cohorts A and B): Platelets >= x ^/L
(For both cohorts A and B): Serum albumin >
COHORTS AND EXCLUSION CRITERIA
Prior yttrium- therapy for patients in cohorts or
For hypomethylating failure cohorts only, more than months since last cycle of HMA
For which there are no standard therapies available (Cohorts , , and )
For the combination cohorts (cohorts and in Part ) and Part , subjects with metastatic melanoma or NSCLC do not need to have received prior therapy
Subjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors with curative intent or planned systemic anti-cancer therapy, with the exception of immunotherapy in the combination cohorts (Cohorts and in Part and all subjects in Part ).
Previous treatment with lenvatinib (except for participants previously enrolled into Cohorts or B of this study).
Phase II cohorts only: patients must have measurable disease according to RECIST v.. criteria. Patients enrolled in Ph Ib cohorts must have evaluable disease
INCLUSION CRITERIA (ALL COHORTS)
EXCLUSION CRITERIA (ALL COHORTS)
Meets criteria for of the defined study cohorts
ADDITIONAL CRITERIA FOR COHORTS A AND B PARTICIPANTS ONLY: No corticosteroid dosing within days of study therapy initiation
ADDITIONAL CRITERIA FOR COHORTS A AND B PARTICIPANTS ONLY: Cohort a: MGMT promoter unmethylated
For patients enrolling in the four expansion cohorts:
For all cohorts:
For all cohorts:
For both cohorts:
For both cohorts:
Agreement to the collection of serial fresh lesion samples (required, if feasible, for entry into Escalation Cohorts and Expansion Cohorts A & B and optional, but encouraged in Escalation Cohorts & and Expansion Cohort C)
ALL COHORTS
Dose Expansion: Solid Tumors Not Otherwise Eligible for the Cholangiocarcinoma, Chondrosarcoma, or Non-enhancing Glioma Cohorts
Participants enrolling in the indication-specific expansion cohorts in Stage must consent to tumor biopsies and must have one of the following types of cancer:
Participants for Cohorts B and C:
Participants for Cohorts D and E:
Participants for Cohorts A, C, and E:
Potential Participants for Cohorts A, C or E who are to Receive Binimetinib:
Potential Participants for Cohorts A, C, D or E:
Potential Participants for Cohorts D or E:
Albumin >= . g/dL\r\n* NOTE: this applies to patient in the normal and renal dysfunction cohorts (N, R and R); abnormal albumin is allowed for patients in the liver dysfunction cohorts
FURTHER ELIGIBILITY DETAILS FOR PATIENTS WITH PROGRESSIVE DISEASE (COHORTS AND A/B):
Any prior treatment with capecitabine for patients enrolled to cohorts a/b and prior lapatinib for participants on cohort a
Safety and Expansion Cohorts
Part (Expansion) only: Subject must be able to be stratified into of cohorts:
MESOTHELIOMA COHORTS (COHORTS AND ONLY): Total bilirubin =< . x institutional upper limit of normal (ULN)
Total bilirubin: see guidelines for individual cohorts
B) Dose Expansion Cohorts:
for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)
For participants in all combination arms (Cohorts A-E), use or consumption of any of the following substances:
Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: - (dose escalation cohorts) or - (expansion cohorts)
Cohorts A & B:
Patients will be enrolled in one of the two cohorts based on diagnosis:
NSCLC patients of all histologies may enroll to cohorts and ; only patients of non-squamous histologies may enroll to cohort ; if enrollment to a cohort is completed, enrollment may continue to other open cohorts
Dose and Disease Expansion Cohorts
Part : Subjects will be enrolled into of cohorts:
Note, the line of therapy limit does not apply to the biopsy substudy cohorts.
For participants enrolled in the expansion cohorts in which tumor biopsies are obtained: