CLINICAL TRIALS PROFILE FOR INCB050465

Clinical Trials for INCB050465

Trial ID	Title	Status	Sponsor	Phase	Summary
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)	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.
NCT02265510 ↗	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).
NCT02559492 ↗	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.
NCT02646748 ↗	Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors	Active, not recruiting	Incyte Corporation	Phase 1	This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2). Two treatment groups (Group A and Group B) will be evaluated Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).
NCT02718300 ↗	A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis	Active, not recruiting	Incyte Corporation	Phase 2	The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
NCT02998476 ↗	A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)	Completed	Incyte Corporation	Phase 2	The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Clinical Trial Conditions for INCB050465

Condition Name

Condition Name
Intervention	Trials
Lymphoma	7
Myelofibrosis	5
Post Polycythemia Vera Myelofibrosis	4
Primary Myelofibrosis	4

Condition MeSH

Condition MeSH
Intervention	Trials
Lymphoma	15
Neoplasms	7
Lymphoma, B-Cell	5
Primary Myelofibrosis	5

Clinical Trial Locations for INCB050465

Trials by Country

Trials by Country
Location	Trials
United States	262
France	18
Italy	14
Spain	13
United Kingdom	10

Trials by US State

Trials by US State
Location	Trials
California	19
New York	17
Texas	16
Florida	13
Arizona	11

Clinical Trial Progress for INCB050465

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	11
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	12
Active, not recruiting	10
Completed	4

Clinical Trial Sponsors for INCB050465

Sponsor Name

Sponsor Name
Sponsor	Trials
Incyte Corporation	28
National Cancer Institute (NCI)	1
Mayo Clinic	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	29
Other	3
NIH	1