Description:
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).
Title
- Brief Title: An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
- Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
INCB 52793-101
- NCT ID:
NCT02265510
Conditions
Interventions
Drug | Synonyms | Arms |
---|
INCB052793 | | Phase 1a: INCB052793 Monotherapy |
gemcitabine | Gemzar® | Phase 1b: INCB052793 Combination Therapy |
nab-paclitaxel | Abraxane® | Phase 1b: INCB052793 Combination Therapy |
dexamethasone | | Phase 1b: INCB052793 Combination Therapy |
Carfilzomib | Kyprolis® | Phase 1b: INCB052793 Combination Therapy |
bortezomib | Velcade® | Phase 1b: INCB052793 Combination Therapy |
lenalidomide | Revlimid® | Phase 1b: INCB052793 Combination Therapy |
azacitidine | Vidaza® | Phase 1b: INCB052793 Combination Therapy |
INCB052793 | | Phase 1b: INCB052793 Combination Therapy |
pomalidomide | Pomalyst® | Phase 1b: INCB052793 Combination Therapy |
INCB050465 | | Phase 1b: INCB052793 Combination Therapy |
INCB039110 | itacitinib | Phase 2: INCB052793 and itacitinib Combination Therapy |
Purpose
This is a study of INCB052793 given to patients with advanced malignancies that will 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 will have two parts; a dose escalation (Part 1) and an expansion (Part 2).
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1a: INCB052793 Monotherapy | Experimental | | |
Phase 1b: INCB052793 Combination Therapy | Experimental | | - gemcitabine
- nab-paclitaxel
- dexamethasone
- Carfilzomib
- bortezomib
- lenalidomide
- azacitidine
- INCB052793
- pomalidomide
- INCB050465
|
Phase 2: INCB052793 and itacitinib Combination Therapy | Experimental | | - azacitidine
- INCB052793
- INCB039110
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Adverse events that are defined as dose limiting toxicities occurring during the first cycle of treatment (Phase 1a - 21 days; Phase 1b - 21 or 28 days depending upon treatment regimen ) |
Time Frame: | Phase 1a - Baseline through Day 21; Phase 1b - Baseline through Day 21 or 28, depending upon treatment regimen |
Safety Issue: | |
Description: | Objective Response Rate determined by investigator evaluation of disease assessments using criteria relevant to the malignancy type |
Secondary Outcome Measures
Measure: | Plasma concentrations of INCB052793 (Phase 1a and Phase 1b) and the background standard of care agent(s) (Phase 1b and Phase 2 only) |
Time Frame: | Phase 1a: Day 15 of treatment at a given dose; Phase 1b and Phase 2: Day 5, 8, or 15 of treatment at a given dose, depending upon treatment regimen |
Safety Issue: | |
Description: | Blood plasma samples will be collected prior to and at 0.5, 1, 2, 4, 6 hours after administration of INCB052793 in Phase 1a, and prior to and at various timepoints from 5 minutes to 8 hours after administration of INCB052793 in Phase 1b and Phase 2, depending upon treatment regimen . Plasma concentrations of INCB052793, the background chemotherapeutic agents (Phase 1b and Phase 2 only) and itacitinib (Phase 2 only) will be determined by the use of validated assays. |
Measure: | Phase 1a, Part 2 only: Plasma concentrations of INCB052793 in the fed state |
Time Frame: | Cycle 2, Day 1 of treatment in this cohort |
Safety Issue: | |
Description: | Blood plasma samples will be collected prior to and at 0.5, 1, 2, 4, 6 hours after administration of INCB052793 in Phase 1a. Plasma concentrations of INCB052793 will be determined by the use of a validated assay. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Incyte Corporation |
Last Updated
November 7, 2017