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

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ClinicalTrials.gov Identifier: NCT01905813
Recruitment Status : Active, not recruiting
First Posted : July 23, 2013
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
B-cell Malignancies Drug: INCB040093 Drug: INCB040093 + itacitinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Study Start Date : June 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: INCB040093 Drug: INCB040093
Escalating doses starting at 100 mg every day (QD)
Drug: INCB040093
INCB040093 monotherapy - dose to be determined at completion of Phase I of the study
Experimental: INCB040093 in combination with itacitinib (INCB039110) Drug: INCB040093 + itacitinib
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.
Other Name: itacitinib (INCB039110)



Primary Outcome Measures :
  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 [ Time Frame: Measured every 3 weeks until progression. ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetic (PK) collections. [ Time Frame: Measured for each patient at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15 ]
    Plasma concentrations of each INCB040093 and itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905813


Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Florida
Jacksonville, Florida, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Peter Langmuir, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01905813     History of Changes
Other Study ID Numbers: INCB 40093-102
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Neoplasms