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

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumors, Advanced Malignancies, Metastatic Cancer

In brief

This was a study of INCB052793 given to patients with advanced malignancies that was to 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 had two parts; a dose escalation (Part 1) and an expansion (Part 2).

Key facts

Study ID

NCT02265510

Run by

Incyte Corporation

People needed

83

Starts

2014-09-10

Expected to finish

2019-02-27

Last updated by the study team

2020-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — West Hollywood, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Greenville, South Carolina, United States
• Site 2 — Nashville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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