Overview

This trial is active, not recruiting.

Condition b-cell malignancies
Treatments incb040093, incb040093 + itacitinib
Phase phase 1
Sponsor Incyte Corporation
Start date June 2013
End date May 2017
Trial size 121 participants
Trial identifier NCT01905813, INCB 40093-102

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
incb040093
Escalating doses starting at 100 mg every day (QD)
incb040093
INCB040093 monotherapy - dose to be determined at completion of Phase I of the study
(Experimental)
incb040093 + itacitinib itacitinib (INCB039110)
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.

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria

  • 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.

Additional Information

Official title A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Incyte Corporation.