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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT01905813
Phase
PHASE1
Status
Completed

Conditions

  • B-cell Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2013
Status verified
May 2026
Primary completion
Feb 26, 2026
Completion
Feb 26, 2026

Study Design

Enrollment
121 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: INCB040093
  • Experimental: INCB040093 in combination with itacitinib (INCB039110)

Primary Outcome Measure

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. ]

Locations (6)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-JacksonvilleFlorida--
-Ann ArborMichigan--
-RochesterMinnesota--
-New YorkNew York--
-RochesterNew York--

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