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

• Status: Terminated
• Trial end date: 2019-02-27
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Azacitidine; BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine; Lenalidomide; Paclitaxel; Pomalidomide

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