[c09aa8]: / clusters / 9knumclustersv2 / clust_2919.txt

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Patients with any polymorphism in UGTA other than * or * (e.g., *) will be allowed and treated as in the */* dosing group
Homozygous for the UGTA* allele (UGTA / genotype) or heterozygotes for UGTA* (UGTA / genotype) only for the phase I part
Concurrent use of any medication that is an inhibitor of UGTA during the screening or treatment period
UGTA* homozygote or heterozygote
Subjects who are homozygous for the UGTA* allele
Use of UDP glucuronosyltransferase family, polypeptide A (UGTA) inhibitor including: diclofenac, imipramine, and ketoconazole
Use of any UGTA inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Use of any UGTA inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Use of any UGTA inhibitor while on active study treatment, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Subjects with UGTA* polymorphisms.
Concomitant use of a UGTA inhibitor, such as idinavir, atazanavir and sorafenib, throughout the study period.
Patients who require treatment with UGTA inhibitors during the period of investigational treatment with DFP-.
Patients with known Gilbert's syndrome or reduced UGTA activity.
Uridine diphosphate (UDP) glycosyltransferase family, polypeptide A (UGTA) * homozygous patients
Use of drugs known to inhibit UGTA, such as atazanir, gemfibrozil, indinavir, or ketoconazole, within weeks prior to start of study treatment
UGTA genotyping prior to treatment
UGTA genotype other than */*, */*, or */*
Patients on a medication or herbal therapy known to inhibit cytochrome P (CYP)A, UGTA, or UGTB
DOSE ESCALATION COHORT: Use of any UGTA inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
DOSE EXPANSION COHORT: Use of any UGTA inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Use of any uridine diphosphate (UDP) glucuronosyltransferase family, polypeptide A (UGTA) inhibitor including: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid from screening through follow-up period
Use of any UDP glucuronosyltransferase family, polypeptide A (UGTA) inhibitor including: acitretin, amitriptyline, androsterone, cyclosporine, dasatinib, diclofenac, diflunisal, efavirenz, erlotinib, estradiol (-beta), flutamide, gefitinib, gemfibrozil, glycyrrhetinic acid, glycyrrhizin, imatinib, imipramine, ketoconazole, linoleic acid, mefenamic acid, mycophenolic acid, niflumic acid, nilotinib, phenobarbital, phenylbutazone, phenytoin, and probenecid propofol, quinidine, ritonavir, sorafenib, sulfinpyrazone, valproic acid, and verapamil; patients must avoid UGTA inhibitors from the screening period through active treatment with INCB and for one week after discontinuation of INCB
Patients with any polymorphism in UGTA other than * or * (e.g., *)
Patients must not have a known history of Gilberts syndrome or known homozygosity for the UDP glucuronosyltransferase family, polypeptide A (UGTA)* allele
Evidence of Gilberts syndrome or known homozygosity for the UGTA* allele (special screening not required)
A history of known Gilberts syndrome or homozygous presence of the uridine diphosphate (UDP)-glucuronosyltransferase family, polypeptide A (UGTA)* allele on pre-treatment testing
Patients who are already known homozygous for the UDP glycosyltransferase family, polypeptide A (UGTA)* allele, and patients of Asian descent homozygous or heterozygous for the UGTA* allele will be excluded
Total bilirubin =< x ULN (except for patients with uridine diphosphate glucuronosyltransferase A [UGTA] promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or invader UGTA molecular assay prior to study enrollment; patients enrolled with Gilbert syndrome must have total bilirubin < ULN)
Patients with any polymorphism in UGTA other than * or * (e.g, *)
Any known UGTA polymorphism, heterozygous or homozygous
UGTA genotype of TA in both alleles (homozygous UGTA*) or TA in either one or both alleles (hetero- or homozygous for UGTA*)
UGTA genotype of TA in both alleles (homozygous UGTA*) or TA in either one or both alleles (hetero- or homozygous for UGTA*)
Homozygous UDP glucuronosyltransferase family, polypeptide A (UGTA)* (i.e. TA repeats) gene alleles; the UGTA test should be conducted per local institutional practice
Patients genotyped for UGTA* polymorphism with */* or */* genotype
Patients with any polymorphism in UGTA other than * or * (e.g, *)
Patients with Gilberts syndrome unless homozygosity for the uridine diphosphate (UDP) glucuronosyltransferase family, polypeptide A (UGTA)* mutation has been excluded
Known homozygous for UGTA* mutation from prior testing or family history
Requirement of therapy with a UGTA Inhibitor, or use within days of enrollment on this protocol