An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
NCT02265510 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2020-04-17
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).
Conditions
- Solid Tumors
- Advanced Malignancies
- Metastatic Cancer
Interventions
- DRUG
-
INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
- DRUG
-
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
- DRUG
-
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
- DRUG
-
Dexamethasone administered orally at the protocol-specified dose and frequency.
- DRUG
-
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
- DRUG
-
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
- DRUG
-
Lenalidomide administered orally at the protocol-specified dose and frequency.
- DRUG
-
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
- DRUG
-
INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
- DRUG
-
Pomalidomide administered orally at the protocol-specified dose and frequency.
- DRUG
-
INCB050465
INCB050465 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Ekaterine Asatiani, M.D. · Incyte Corporation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-10
- Primary Completion
- 2019-02-27
- Completion
- 2019-02-27
Countries
- United States
Study Locations
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