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

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ClinicalTrials.gov Identifier: NCT02265510
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 16, 2014
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • 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 ]
  • Objective Response Rate [ Time Frame: Baseline through end of study. Approximately 24 months ]
    Objective Response Rate determined by investigator evaluation of disease assessments using criteria relevant to the malignancy type
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Adverse events that are defined as dose limiting toxicities occurring during the first cycle of treatment (Phase 1a - 21 days; Phase 1b - 28 days ) [ Time Frame: Phase 1a - Baseline through Day 21; Phase 1b - Baseline through Day 28 ]
Change History Complete list of historical versions of study NCT02265510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • 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 ]
    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.
  • Phase 1a, Part 2 only: Plasma concentrations of INCB052793 in the fed state [ Time Frame: Cycle 2, Day 1 of treatment in this cohort ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
  • Objective Response Rate [ Time Frame: Baseline through end of study. Approximately 24 months ]
    Objective Response Rate determined by investigator evaluation of radiographic disease assessments
  • Plasma concentrations of INCB052793 (Phase 1a and Phase 1b) and the background chemotherapeutic agent(s) (Phase 1b only) [ Time Frame: Phase 1a: Day 15 of treatment at a given dose; Phase 1b: Day 8 of treatment at a given dose ]
    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 0.5, 1, 2, 3, and 5 hours after administration of INCB052793 in Phase 1b . Plasma concentrations of INCB052793 and the background chemotherapeutic agents (Phase 1b only) will be determined by the use of validated assays.
  • Phase 1a, Part 2 only: Plasma concentrations of INCB052793 in the fed state. [ Time Frame: Cycle 2, Day 1 of treatment in this cohort ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
Official Title  ICMJE A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Advanced Malignancies
  • Metastatic Cancer
Intervention  ICMJE
  • Drug: INCB052793
    Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
  • Drug: gemcitabine
    Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
    Other Name: Gemzar®
  • Drug: nab-paclitaxel
    nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
    Other Name: Abraxane®
  • Drug: dexamethasone
    Dexamethasone administered orally at the protocol-specified dose and frequency.
  • Drug: Carfilzomib
    Carfilzomib administered intravenously at the protocol-specified dose and frequency.
    Other Name: Kyprolis®
  • Drug: bortezomib
    Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
    Other Name: Velcade®
  • Drug: lenalidomide
    Lenalidomide administered orally at the protocol-specified dose and frequency.
    Other Name: Revlimid®
  • Drug: azacitidine
    Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
    Other Name: Vidaza®
  • Drug: INCB052793
    INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
  • Drug: pomalidomide
    Pomalidomide administered orally at the protocol-specified dose and frequency.
    Other Name: Pomalyst®
  • Drug: INCB050465
    INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
  • Drug: INCB039110
    INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
    Other Name: itacitinib
Study Arms  ICMJE
  • Experimental: Phase 1a: INCB052793 Monotherapy
    Intervention: Drug: INCB052793
  • Experimental: Phase 1b: INCB052793 Combination Therapy
    Interventions:
    • Drug: gemcitabine
    • Drug: nab-paclitaxel
    • Drug: dexamethasone
    • Drug: Carfilzomib
    • Drug: bortezomib
    • Drug: lenalidomide
    • Drug: azacitidine
    • Drug: INCB052793
    • Drug: pomalidomide
    • Drug: INCB050465
  • Experimental: Phase 2: INCB052793 and itacitinib Combination Therapy
    Interventions:
    • Drug: azacitidine
    • Drug: INCB052793
    • Drug: INCB039110
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019)
83
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2014)
105
Actual Study Completion Date  ICMJE February 27, 2019
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02265510
Other Study ID Numbers  ICMJE INCB 52793-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ekaterine Asatiani, M.D. Incyte Corporation
PRS Account Incyte Corporation
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP