An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
NCT ID: NCT02265510
Last Updated: 2020-04-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
83 participants
INTERVENTIONAL
2014-09-10
2019-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1a: INCB052793 Monotherapy
INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
Phase 1b: INCB052793 Combination Therapy
gemcitabine
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
nab-paclitaxel
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
dexamethasone
Dexamethasone administered orally at the protocol-specified dose and frequency.
Carfilzomib
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
bortezomib
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
lenalidomide
Lenalidomide administered orally at the protocol-specified dose and frequency.
azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
pomalidomide
Pomalidomide administered orally at the protocol-specified dose and frequency.
INCB050465
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
Phase 2: INCB052793 and itacitinib Combination Therapy
azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
INCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Interventions
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INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
gemcitabine
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
nab-paclitaxel
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
dexamethasone
Dexamethasone administered orally at the protocol-specified dose and frequency.
Carfilzomib
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
bortezomib
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
lenalidomide
Lenalidomide administered orally at the protocol-specified dose and frequency.
azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
pomalidomide
Pomalidomide administered orally at the protocol-specified dose and frequency.
INCB050465
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
INCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ekaterine Asatiani, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham, Alabama, United States
West Hollywood, California, United States
New Haven, Connecticut, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Hackensack, New Jersey, United States
New York, New York, United States
Durham, North Carolina, United States
Portland, Oregon, United States
Greenville, South Carolina, United States
Site 2
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 52793-101
Identifier Type: -
Identifier Source: org_study_id
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