[c09aa8]: / clusters / ordered9kclusters / clust_1192.txt

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Dose Expansion (Segment 2): 0 - 2
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Part I dose escalation: Participants are required to have measurable disease per RECIST 1.1 within 4 weeks of study entry
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Participants are permitted to have any number of prior therapies prior to enrollment
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Absolute neutrophil count >= 1,500 mm^3
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Hemoglobin >= 9 g/dL
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Platelets >= 100,000/mcL
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Total bilirubin =< 2 X institutional upper limit of normal (ULN)
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: AST (SGOT)/ALT (SGPT) =< 5.0 X ULN if hepatic metastases are present
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Creatinine =< 1.5 X the institutional ULN OR
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: MTD expansion: Patients must be willing to undergo pre- and on-treatment tumor biopsies; patients are exempt from this requirement if, in the opinion of the investigator, the biopsy procedure would pose a significant risk or if they have only pulmonary metastatic disease
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Patients must be able to take oral medications
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Corrected QT (QTc) =< 480 msec
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Participants receiving any other study agents concurrently with the study drugs
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: MTD expansion: Patients currently taking anticoagulants and who cannot safely hold the medication to facilitate pre and on-treatment tumor biopsies are excluded from participation
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Part I dose escalation: Concurrent use of proton-pump inhibitors (PPIs) is prohibited
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of QT syndrome, Brugada syndrome, known history of QTc prolongation, or Torsades de Pointes
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of Gilbert’s syndrome
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Patients planning to embark on a new strenuous exercise regimen after the first dose of study treatment
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of retinal degenerative disease
Dose Expansion: Cholangiocarcinoma
For expansion part:
Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
For dose expansion participants who will have tumor biopsies collected: