NCT02018861

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)

A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Iitacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-Cell Malignancies

Interventions

Type	Name	Description
DRUG	Parsaclisib
DRUG	Itacitinib
DRUG	Rituximab
DRUG	Ifosfamide
DRUG	Carboplatin
DRUG	Etoposide

Timeline

• Start date: 2016-09-22
• Primary completion: 2021-04-12
• Completion: 2021-04-12
• First posted: 2013-12-23
• Last updated: 2023-09-28
• Results posted: 2022-06-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study