drugset / Trial / 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)
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itacitinib | Small molecule | 300 mg | Oral |
| Subject | Parsaclisib | Small molecule | 5 mg | Oral |
| Subject | Parsaclisib | Small molecule | 10 mg | Oral |
| Subject | Parsaclisib | Small molecule | 15 mg | Oral |
| Subject | Parsaclisib | Small molecule | 20 mg | Oral |
| Subject | Parsaclisib | Small molecule | 30 mg | Oral |
| Subject | Parsaclisib | Small molecule | 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 |