Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/12/2018 |
Start Date: | June 2013 |
End Date: | December 2019 |
A Phase 1, Open-label, Dose Escalation, Safety and Tolerability 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.
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.
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.
We found this trial at
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