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Completed

NCT Number: NCT01905813

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 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.

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Key information

Conditions

B-cell Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows:

*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma:

EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma

INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, transformed NHL histologies, etc.

*Hodgkin's lymphoma

  • Life expectancy of 12 weeks or longer.
  • Subject must have received ≥ 1 prior treatment regimen.
  • The subject must not be a candidate for potentially curative therapy, including stem cell transplant.

Exclusion criteria

  • Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
  • Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
  • Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.
  • Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3.
  • Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
  • Received autologous hematopoietic stem cell transplant within the last 3 months.
  • Laboratory parameters not within the protocol-defined range.
  • Current or recent history (<30 days prior to screening and/or <45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection.
  • Current clinically active viral infection.
  • Known history of infection with the human immunodeficiency virus (HIV).
  • History of active hepatitis or positive serology for hepatitis.

Treatment and study plan

INCB040093

Drug

Escalating doses starting at 100 mg every day (QD)

INCB040093 + itacitinib

Drug

INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.

Other names: itacitinib (INCB039110)

Primary outcomes

  1. Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

    Time frame: Measured every 3 weeks until progression.

Secondary outcomes

  1. Preliminary efficacy as assessed by Overall Response Rate (ORR) as measured by published criteria for Hodgkin's/non-Hodgkin's lymphoma (Cheson et al 2007 and Owen et al 2013) and Chronic Lymphocytic Leukemia (CLL) (Cheson et el 2012)

    Time frame: Every 12 weeks (4 cycles) until study withdrawal

  2. Pharmacokinetic (PK) collections.

    Time frame: Measured for each patient at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15

    Plasma concentrations of each INCB040093 and itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2013
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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