A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Completed
Incyte Corporation
Phase 1/Phase 2
Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to
find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor,
parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1
inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib
inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
Terminated
Incyte Corporation
Phase 1/Phase 2
This was a study of INCB052793 given to patients with advanced malignancies that was to be
conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and
Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine).
Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).
Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors
Terminated
Incyte Corporation
Phase 1
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid
tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will
evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1
inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta
inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses
for each combination. Once the recommended dose has been identified for each treatment group
in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based
upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2,
additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib
and INCB050465 in subjects with select tumor types.
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