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ACTIVE NOT RECRUITING Phase 1

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

NCT01905813 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 121 participants
Start Date 2013-06-30
Est. Completion 2026-04-17
Phase Phase 1

Sponsor

Incyte Corporation

163 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01905813

The ClinicalTrials.gov registry entry for NCT01905813 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01905813 reports 6 study locations spanning 5 distinct geographic areas — top geographies include New York, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01905813?

The interventions under investigation include: INCB040093 (DRUG), INCB040093 + itacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01905813?

This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial