Clinical Trials /

An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

NCT02265510

Description:

This is a study of INCB052793 given to patients with advanced malignancies that will be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 will have two parts; a dose escalation (Part 1) and an expansion (Part 2).

Related Conditions:
  • Acute Myeloid Leukemia
  • Breast Carcinoma
  • Cancer
  • Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Pancreatic Adenocarcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
  • Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: INCB 52793-101
  • NCT ID: NCT02265510

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
INCB052793Phase 1a: INCB052793 Monotherapy
gemcitabineGemzar®Phase 1b: INCB052793 Combination Therapy
nab-paclitaxelAbraxane®Phase 1b: INCB052793 Combination Therapy
dexamethasonePhase 1b: INCB052793 Combination Therapy
CarfilzomibKyprolis®Phase 1b: INCB052793 Combination Therapy
bortezomibVelcade®Phase 1b: INCB052793 Combination Therapy
lenalidomideRevlimid®Phase 1b: INCB052793 Combination Therapy
azacitidineVidaza®Phase 1b: INCB052793 Combination Therapy
INCB052793Phase 1b: INCB052793 Combination Therapy
pomalidomidePomalyst®Phase 1b: INCB052793 Combination Therapy
INCB050465Phase 1b: INCB052793 Combination Therapy
INCB039110itacitinibPhase 2: INCB052793 and itacitinib Combination Therapy

Purpose

This is a study of INCB052793 given to patients with advanced malignancies that will be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 will have two parts; a dose escalation (Part 1) and an expansion (Part 2).

Trial Arms

NameTypeDescriptionInterventions
Phase 1a: INCB052793 MonotherapyExperimental
  • INCB052793
Phase 1b: INCB052793 Combination TherapyExperimental
  • gemcitabine
  • nab-paclitaxel
  • dexamethasone
  • Carfilzomib
  • bortezomib
  • lenalidomide
  • azacitidine
  • INCB052793
  • pomalidomide
  • INCB050465
Phase 2: INCB052793 and itacitinib Combination TherapyExperimental
  • azacitidine
  • INCB052793
  • INCB039110

Eligibility Criteria

        Inclusion Criteria:

        Phase 1a

          -  Aged 18 years or older

          -  Histologically or cytologically confirmed solid tumor or hematologic malignancy

          -  Life expectancy of 12 weeks or longer

          -  Must have received ≥ 1 prior treatment regimen

          -  Must not be a candidate for potentially curative or standard of care approved therapy

        Phase 1b

          -  Aged 18 years or older

          -  Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma,
             triple-negative breast cancer, urothelial cancer with at least 1 measurable or
             evaluable target lesion

          -  Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and
             measureable/evaluable disease

          -  Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome

          -  Cohort H: Individuals diagnosed with lymphoma

          -  Prior therapy:

               -  Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic
                  disease (not including neoadjuvant and/or adjuvant therapy)

               -  Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2
                  prior treatment regimens

               -  Cohort F: May have received any number of prior treatment regimens or be
                  treatment-naïve

               -  Cohort H: Must have relapsed from or have been refractory to available treatments

        Phase 2

          -  Aged 18 years or older

          -  Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic
             syndrome

          -  Prior therapy:

               -  Cohorts I and J: Must have failed prior therapy with a hypomethylating agent
                  (HMA)

        Exclusion Criteria:

          -  Prior receipt of a JAK1 inhibitor (Phase 1a only)

          -  Known active central nervous system metastases and/or carcinomatous meningitis

          -  Eastern Cooperative Oncology Group (ECOG) performance status > 2

          -  Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone,
             carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor
             (Phase 1b and Phase 2 only, as appropriate to treatment cohort)

          -  Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV)
             or hepatitis C virus (HCV) infection or risk of reactivation
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events that are defined as dose limiting toxicities occurring during the first cycle of treatment (Phase 1a - 21 days; Phase 1b - 21 or 28 days depending upon treatment regimen )
Time Frame:Phase 1a - Baseline through Day 21; Phase 1b - Baseline through Day 21 or 28, depending upon treatment regimen
Safety Issue:
Description:Objective Response Rate determined by investigator evaluation of disease assessments using criteria relevant to the malignancy type

Secondary Outcome Measures

Measure:Plasma concentrations of INCB052793 (Phase 1a and Phase 1b) and the background standard of care agent(s) (Phase 1b and Phase 2 only)
Time Frame:Phase 1a: Day 15 of treatment at a given dose; Phase 1b and Phase 2: Day 5, 8, or 15 of treatment at a given dose, depending upon treatment regimen
Safety Issue:
Description:Blood plasma samples will be collected prior to and at 0.5, 1, 2, 4, 6 hours after administration of INCB052793 in Phase 1a, and prior to and at various timepoints from 5 minutes to 8 hours after administration of INCB052793 in Phase 1b and Phase 2, depending upon treatment regimen . Plasma concentrations of INCB052793, the background chemotherapeutic agents (Phase 1b and Phase 2 only) and itacitinib (Phase 2 only) will be determined by the use of validated assays.
Measure:Phase 1a, Part 2 only: Plasma concentrations of INCB052793 in the fed state
Time Frame:Cycle 2, Day 1 of treatment in this cohort
Safety Issue:
Description:Blood plasma samples will be collected prior to and at 0.5, 1, 2, 4, 6 hours after administration of INCB052793 in Phase 1a. Plasma concentrations of INCB052793 will be determined by the use of a validated assay.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Last Updated

November 7, 2017