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)

Conditions

• B-Cell Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Parsaclisib — DRUG
• Itacitinib — DRUG
• Rituximab — DRUG
• Ifosfamide — DRUG
• Carboplatin — DRUG
• Etoposide — DRUG

Study Details

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.

Key Dates

Start date

Sep 22, 2016

Status verified

Sep 2023

Primary completion

Apr 12, 2021

Completion

Apr 12, 2021

Study Design

Enrollment

88 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Parsaclisib 5 mg QD
  Parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles
• Experimental: Parsaclisib 10 mg QD
  Parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles
• Experimental: Parsaclisib 15 mg QD
  Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles
• Experimental: Parsaclisib 20 mg QD
  Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles
• Experimental: Parsaclisib 30 mg QD
  Parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles
• Experimental: Parsaclisib 45 mg QD
  Parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles
• Experimental: Parsaclisib 20 mg + itacitinib (INCB039110) 300 mg
  Parsaclisib 20 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles
• Experimental: Parsaclisib 30 mg + itacitinib (INCB039110) 300 mg
  Parsaclisib 30 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles
• Placebo Comparator: Parsaclisib 15 mg QD + R-ICE
  Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m\^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m\^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m\^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration
• Placebo Comparator: Parsaclisib 20 mg QD + R-ICE
  20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m\^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m\^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m\^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 53 months (4.4 years) ]

Locations (7)

Find similar trials in Birmingham, AL

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