Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
This trial is active, not recruiting.
|Treatments||incb040093, incb040093 + itacitinib|
|Start date||June 2013|
|End date||May 2017|
|Trial size||121 participants|
|Trial identifier||NCT01905813, INCB 40093-102|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||not available||no longer recruiting|
|Birmingham, AL||University of Alabama at Birmingham Cancer Center||no longer recruiting|
|Jacksonville, FL||not available||no longer recruiting|
|Jacksonville, FL||Mayo Clinic in Florida||no longer recruiting|
|Ann Arbor, MI||not available||no longer recruiting|
|Ann Arbor, MI||University of Michigan Comprehensive Cancer Center||no longer recruiting|
|Rochester, MN||not available||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|New York, NY||not available||no longer recruiting|
|New York, NY||Laura and Isaac Perlmutter Cancer Center at NYU Langone||no longer recruiting|
|Rochester, NY||not available||no longer recruiting|
|Intervention model||single group assignment|
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.
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)
time frame: Every 12 weeks (4 cycles) until study withdrawal
Pharmacokinetic (PK) collections.
time frame: Measured for each patient at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15
All participants at least 18 years old.
Inclusion Criteria: • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows: o 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. o 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.
|Official title||A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies|
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