Status:
ACTIVE_NOT_RECRUITING
Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Lead Sponsor:
Incyte Corporation
Conditions:
B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 d...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
June 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2026
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01905813
Start Date
June 30 2013
End Date
April 17 2026
Last Update
December 19 2025
Active Locations (6)
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1
Birmingham, Alabama, United States
2
Jacksonville, Florida, United States
3
Ann Arbor, Michigan, United States
4
Rochester, Minnesota, United States