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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

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).

Condition or disease Intervention/treatment Phase
Solid Tumors Advanced Malignancies Metastatic Cancer Drug: INCB052793 Drug: gemcitabine Drug: nab-paclitaxel Drug: dexamethasone Drug: Carfilzomib Drug: bortezomib Drug: lenalidomide Drug: azacitidine Drug: pomalidomide Drug: INCB050465 Drug: INCB039110 Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : February 27, 2019

Arm Intervention/treatment
Experimental: Phase 1a: INCB052793 Monotherapy Drug: INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.

Experimental: Phase 1b: INCB052793 Combination Therapy 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.

Experimental: Phase 2: INCB052793 and itacitinib Combination Therapy 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: INCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Other Name: itacitinib




Primary Outcome Measures :
  1. 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 ]
  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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

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): NCT02265510


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
West Hollywood, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Oregon
Portland, Oregon, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Tennessee
Site 2
Nashville, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Ekaterine Asatiani, M.D. Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02265510     History of Changes
Other Study ID Numbers: INCB 52793-101
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Dexamethasone
Paclitaxel
Albumin-Bound Paclitaxel
Lenalidomide
Bortezomib
Azacitidine
Pomalidomide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents