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NCT02018861 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT02018861: Completed Phase 1 study, sponsored by Incyte Corporation.
NCT02018861 is a Phase 1 study that has completed, run by Incyte Corporation. The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02018861, a Phase 1 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study 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.
Primary Outcome
An adverse event (AE) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy (e.g., hematologic abnormality that requires transfusion), or require changes in the study drug(s). A T
Interventions
- DRUG Carboplatin
- DRUG Rituximab
- DRUG Ifosfamide
- DRUG Itacitinib
- DRUG Parsaclisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2016-09-22 |
| Est. Completion | 2021-04-12 |
| Phase | Phase 1 |
What the finished NCT02018861 record still lists
NCT02018861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT02018861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02018861 about?
NCT02018861 is a clinical study titled "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)". 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, ...
What is the current status of trial NCT02018861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2016-09-22. Estimated completion is 2021-04-12.
What interventions are being tested in trial NCT02018861?
The interventions under investigation include: Carboplatin (DRUG), Rituximab (DRUG), Ifosfamide (DRUG), Itacitinib (DRUG), Parsaclisib (DRUG).
Who is sponsoring clinical trial NCT02018861?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02018861's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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