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NCT01905813 · ClinicalTrials.gov registry record · Phase 1
Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
A Phase 1 study of B-cell Malignancies, sponsored by Incyte Corporation.
- Active
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
- 6
- Study locations
NCT01905813: Active Phase 1 study of B-cell Malignancies, sponsored by Incyte Corporation.
NCT01905813 is a Phase 1 study of B-cell Malignancies that is active but no longer recruiting, run by Incyte Corporation. The registered enrollment target is 121 participants, below the 314-participant average among 6 other B-cell Malignancies trials with a reported enrollment target (61% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01905813, a Phase 1 study of B-cell Malignancies, is active but no longer recruiting, sponsored by Incyte Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
- 6
- Study locations
Study Summary
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.
Conditions Studied
Interventions
- DRUG INCB040093
- DRUG INCB040093 + itacitinib
Study Locations (6)
New York
- - New York
- - Rochester
Alabama
- - Birmingham
Florida
- - Jacksonville
Michigan
- - Ann Arbor
Minnesota
- - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2013-06-30 |
| Est. Completion | 2026-04-17 |
| Phase | Phase 1 |
What the registry record for NCT01905813 still lists
NCT01905813 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 314-participant average among 6 other B-cell Malignancies trials with a reported enrollment target (61% lower).
The record links to 1 condition, with B-cell Malignancies appearing as the primary indexed condition, and to 2 interventions - of which INCB040093 is the first listed.
NCT01905813 lists 6 locations in 5 states (New York, Alabama, Florida).
Frequently Asked Questions
What is clinical trial NCT01905813 about?
NCT01905813 is a clinical study titled "Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies". The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibito...
What is the current status of trial NCT01905813?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2013-06-30. Estimated completion is 2026-04-17.
What conditions does trial NCT01905813 study?
This clinical trial studies the following conditions: B-cell Malignancies.
What interventions are being tested in trial NCT01905813?
The interventions under investigation include: INCB040093 (DRUG), INCB040093 + itacitinib (DRUG).
Who is sponsoring clinical trial NCT01905813?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01905813 being conducted?
This trial has 6 study locations across Alabama, Florida, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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