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

Incyte

Status and phase

Active, not recruiting

Phase 1

Conditions

B-cell Malignancies

Treatments

Drug: INCB040093 + itacitinib

Drug: INCB040093

Study type

Interventional

Funder types

Industry

Identifiers

NCT01905813

INCB 40093-102

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.