Patients with any polymorphism in UGT1A1 other than *1 or *28 (e.g., *6) will be allowed and treated as in the *28/*28 dosing group
Homozygous for the UGT1A1*28 allele (UGT1A1 7/7 genotype) or heterozygotes for UGT1A1*28 (UGT1A11 7/6 genotype) only for the phase I part
Concurrent use of any medication that is an inhibitor of UGT1A9 during the screening or treatment period
UGT1A1*28 homozygote or heterozygote
Subjects who are homozygous for the UGT1A1*28 allele
Use of UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: diclofenac, imipramine, and ketoconazole
Use of any UGT1A9 inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Use of any UGT1A9 inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Use of any UGT1A9 inhibitor while on active study treatment, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Subjects with UGT1A1*28 polymorphisms.
Concomitant use of a UGT1A1 inhibitor, such as idinavir, atazanavir and sorafenib, throughout the study period.
Patients who require treatment with UGT1A1 inhibitors during the period of investigational treatment with DFP-13318.
Patients with known Gilbert's syndrome or reduced UGT1A1 activity.
Uridine diphosphate (UDP) glycosyltransferase 1 family, polypeptide A1 (UGT1A1) *28 homozygous patients
Use of drugs known to inhibit UGT1A1, such as atazanir, gemfibrozil, indinavir, or ketoconazole, within 2 weeks prior to start of study treatment
UGT1A1 genotyping prior to treatment
UGT1A1 genotype other than *1/*1, *1/*28, or *28/*28
Patients on a medication or herbal therapy known to inhibit cytochrome P450 (CYP)2A6, UGT1A9, or UGT2B7
DOSE ESCALATION COHORT: Use of any UGT1A9 inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
DOSE EXPANSION COHORT: Use of any UGT1A9 inhibitor from screening through follow-up period, including the following: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid
Use of any uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid from screening through follow-up period
Use of any UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: acitretin, amitriptyline, androsterone, cyclosporine, dasatinib, diclofenac, diflunisal, efavirenz, erlotinib, estradiol (17-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 UGT1A9 inhibitors from the screening period through active treatment with INCB024360 and for one week after discontinuation of INCB024360
Patients with any polymorphism in UGT1A1 other than *1 or *28 (e.g., *6)
Patients must not have a known history of Gilbert’s syndrome or known homozygosity for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele
Evidence of Gilbert’s syndrome or known homozygosity for the UGT1A1*28 allele (special screening not required)
A history of known Gilbert’s syndrome or homozygous presence of the uridine diphosphate (UDP)-glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele on pre-treatment testing
Patients who are already known homozygous for the UDP glycosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele, and patients of Asian descent homozygous or heterozygous for the UGT1A1*6 allele will be excluded
Total bilirubin =< 2 x ULN (except for patients with uridine diphosphate glucuronosyltransferase 1A1 [UGT1A1] promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or invader UGT1A1 molecular assay prior to study enrollment; patients enrolled with Gilbert syndrome must have total bilirubin < 3 ULN)
Patients with any polymorphism in UGT1A1 other than *1 or *28 (e.g, *6)
Use of drugs known to inhibit UDP glycosyltransferase 1 family, polypeptide A1 gene (UGT1A1), such as Atazanavir, Gemfibrozil, Indinavir, or Ketoconazole while on study treatment; (patients using these drugs must not take these drugs on the day study treatment begins and for the duration of study treatment)
Any known UGT1A polymorphism, heterozygous or homozygous
UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37)
UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37)
Homozygous UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 (i.e. 7 TA repeats) gene alleles; the UGT1A1 test should be conducted per local institutional practice
Patients genotyped for UGT1A1*28 polymorphism with *1/*1 or *1/*28 genotype
Patients with any polymorphism in UGT1A1 other than *1 or *28 (e.g, *6)
Patients with Gilbert’s syndrome unless homozygosity for the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 mutation has been excluded
Known homozygous for UGT1A1*28 mutation from prior testing or family history
Requirement of therapy with a UGT1A1 Inhibitor, or use within 7 days of enrollment on this protocol