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

NCT01905813 | Active Not Recruiting Phase 1

• 1 other identifier: INCB 40093-102
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 6

Brief 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

B-cell Malignancies

Outcome Measures

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

  Measured every 3 weeks until progression.

Secondary Outcomes (2)

• 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)

  Every 12 weeks (4 cycles) until study withdrawal

• Pharmacokinetic (PK) collections.

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

Study Arms (2)

INCB040093

EXPERIMENTAL

Drug: INCB040093

INCB040093 in combination with itacitinib (INCB039110)

EXPERIMENTAL

Drug: INCB040093 + itacitinib

Interventions

INCB040093 DRUG

Escalating doses starting at 100 mg every day (QD)

INCB040093

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.

Also known as: itacitinib (INCB039110)

INCB040093 in combination with itacitinib (INCB039110)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (6)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Related Publications (1)

• Phillips TJ, Forero-Torres A, Sher T, Diefenbach CS, Johnston P, Talpaz M, Pulini J, Zhou L, Scherle P, Chen X, Barr PM. Phase 1 study of the PI3Kdelta inhibitor INCB040093 +/- JAK1 inhibitor itacitinib in relapsed/refractory B-cell lymphoma. Blood. 2018 Jul 19;132(3):293-306. doi: 10.1182/blood-2017-10-812701. Epub 2018 Apr 25.

  PMID: 29695516 DERIVED

Related Links

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

MeSH Terms

Interventions

itacitinib; INCB039110

Study Officials

• Peter Langmuir, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 23, 2013
• Study Start: June 30, 2013
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (6)