Status:
TERMINATED
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Advanced Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2019
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT02265510
Start Date
September 10 2014
End Date
February 27 2019
Last Update
April 17 2020
Active Locations (14)
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1
Birmingham, Alabama, United States
2
West Hollywood, California, United States
3
New Haven, Connecticut, United States
4
Atlanta, Georgia, United States