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)

NCT02018861 ↗

Phase 1/2 Completed 88 enrolled Incyte Corporation

Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start: 2016-09-22
Primary completion: 2021-04-12
Completion: 2021-04-12

Publications

Forero-Torres A, Ramchandren R, Yacoub A, Wertheim MS, Edenfield WJ, Caimi P, Gutierrez M, Akard L, Escobar C, Call J, Persky D, Iyer S, DeMarini DJ, Zhou L, Chen X, Dawkins F, Phillips TJ. Parsaclisib, a potent and highly selective PI3Kdelta inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood. 2019 Apr 18;133(16):1742-1752. doi: 10.1182/blood-2018-08-867499. Epub 2019 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itacitinib	Small molecule	300 mg	Oral
Subject	Parsaclisib	Unknown	5 mg	Oral
Subject	Parsaclisib	Unknown	10 mg	Oral
Subject	Parsaclisib	Unknown	15 mg	Oral
Subject	Parsaclisib	Unknown	20 mg	Oral
Subject	Parsaclisib	Unknown	30 mg	Oral
Subject	Parsaclisib	Unknown	45 mg	Oral
Comparator	Carboplatin	Small molecule	—	Intravenous
Comparator	Etoposide	Small molecule	100 mg/m2	Intravenous
Comparator	Ifosfamide	Small molecule	5000 mg/m2	Intravenous
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

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)

Summary

Timeline

Publications

Drugs

Indications