Solid Tumors and Hematologic MalignancyPhase 1/2NCT02712905
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
A Phase 1/2 study testing INCB059872, all-trans retinoic acid (ATRA) and azacitidine in people with Solid Tumors and Hematologic Malignancy, run by Incyte Corporation at 15 sites in 3 countries.
Trial summary
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors and Hematologic Malignancy
- What is being tested?
- INCB059872, all-trans retinoic acid (ATRA) and azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 5 May 2016to 14 Apr 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, age 18 years or older.
- Presence of measurable disease that has been confirmed by histology or cytology.
- Must not be a candidate for potentially curative therapy or standard-of-care approved therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Who cannot join
- Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
- Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
- Laboratory and medical history parameters outside Protocol-defined range.
- Known additional malignancy that is progressing or requires active treatment.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States11 sites
University of Alabama
Birmingham, Alabama, 35487
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern University
Chicago, Illinois, 60208
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Kansas Center for Research, Inc.
Kansas City, Kansas, 66045
Moores UCSD Cancer Center
La Jolla, California, 92093
UCLA Medical Center
Los Angeles, California, 90095
Vanderbilt University
Nashville, Tennessee, 37240
Columbia University
New York, New York, 10027
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health Science University
Portland, Oregon, 97297
Netherlands3 sites
Netherland Cancer Institute
Amsterdam
VU Medical Center
Amsterdam
Erasmus MC
Rotterdam
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.
- Conditions
- Solid Tumors and Hematologic Malignancy
- Being tested
- INCB059872, all-trans retinoic acid (ATRA), azacitidine, nivolumab
- Keywords
- Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), small cell lung cancer (SCLC), myelofibrosis (MF), solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Small Cell Lung Carcinoma, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB059872Drug
Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.
INCB059872 tablets to be administered by mouth.
all-trans retinoic acid (ATRA)Drug
azacitidineDrug
nivolumabDrug
| Study group | Role | What they receive |
|---|---|---|
| INCB059872 | Experimental | Not described Receives: Drug: INCB059872 |
| INCB059872 in combination with other therapies | Experimental | Initial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups:
* Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML.
* Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML
* Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment.
Upon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s). Receives: Drug: INCB059872; Drug: all-trans retinoic acid (ATRA); Drug: azacitidine; Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
Measured: up to 588 days
Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
Measured: up to 1387 days
Secondary outcomes (17)
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 518 days
ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10^9/Liter (L), platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.
Measured: up to 85 days
ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.
Measured: up to 61 days
Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy
Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.
Measured: Baseline; Week 12
Cmax of INCB059872 in Plasma When Received as Monotherapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Tmax of INCB059872 in Plasma When Received as Monotherapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy
AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
t1/2 of INCB059872 in Plasma When Received as Monotherapy
t1/2 was defined as the half-life of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
CL/F of INCB059872 in Plasma When Received as Monotherapy
CL/F was defined as the apparent oral clearance of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ORR in Participants With SCLC Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 1353 days
ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10^9/L, platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.
Measured: up to 208 days
ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.
Measured: up to 85 days
Cmax of INCB059872 in Plasma When Received as Combination Therapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Tmax of INCB059872 in Plasma When Received as Combination Therapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy
AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
t1/2 of INCB059872 in Plasma When Received as Combination Therapy
t1/2 was defined as the half-life of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
CL/F of INCB059872 in Plasma When Received as Combination Therapy
CL/F was defined as the apparent oral clearance of INCB059872.
Measured: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start5 May 2016
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Why it stopped: Strategic Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid Tumors and Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Zheng, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712905
- Sponsor's protocol ID
- INCB 59872-101
- Other IDs
- 2017-001710-28, 2017
- Status last verified
- Oct 2025
- First submitted
- 18 Feb 2016
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02712905
- Acronym / sponsor ID
- INCB 59872-101
- Conditions
- Solid Tumors and Hematologic Malignancy
- Keywords
- Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), small cell lung cancer (SCLC), myelofibrosis (MF), solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic Business Decision
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 May 2016 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCB059872 | Experimental | Drug: INCB059872 |
| INCB059872 in combination with other therapies | Experimental | Drug: INCB059872, Drug: all-trans retinoic acid (ATRA), Drug: azacitidine, Drug: nivolumabInitial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups: * Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML. * Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML * Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment. Upon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, age 18 years or older.
- Presence of measurable disease that has been confirmed by histology or cytology.
- Must not be a candidate for potentially curative therapy or standard-of-care approved therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Key exclusion criteria (4 listed)
- Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
- Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
- Laboratory and medical history parameters outside Protocol-defined range.
- Known additional malignancy that is progressing or requires active treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB059872Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts. INCB059872 tablets to be administered by mouth. | Drug | INCB059872, INCB059872 in combination with other therapies |
| all-trans retinoic acid (ATRA) | Drug | INCB059872 in combination with other therapies |
| azacitidine | Drug | INCB059872 in combination with other therapies |
| nivolumab | Drug | INCB059872 in combination with other therapies |
Primary outcome
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 588 days
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE
Time frame: up to 1387 days
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
17 secondary outcomes
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy
Time frame: up to 518 days
ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy
Time frame: up to 85 days
ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy
Time frame: up to 61 days
Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy
Time frame: Baseline; Week 12
Cmax of INCB059872 in Plasma When Received as Monotherapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Tmax of INCB059872 in Plasma When Received as Monotherapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
t1/2 of INCB059872 in Plasma When Received as Monotherapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
CL/F of INCB059872 in Plasma When Received as Monotherapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ORR in Participants With SCLC Who Received Combination Therapy
Time frame: up to 1353 days
ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy
Time frame: up to 208 days
ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy
Time frame: up to 85 days
Cmax of INCB059872 in Plasma When Received as Combination Therapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Tmax of INCB059872 in Plasma When Received as Combination Therapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
t1/2 of INCB059872 in Plasma When Received as Combination Therapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
CL/F of INCB059872 in Plasma When Received as Combination Therapy
Time frame: Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Solid Tumors and Hematologic Malignancy
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Enrolling by invitationObservational study
Follow-Up for Study Participants Treated With an Allogeneic CAR T Cell Product
Hematologic Malignancies, Solid Tumors
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Zheng, MD study director
Incyte Corporation
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCB059872, all-trans retinoic acid (ATRA) and azacitidine in people with Solid Tumors and Hematologic Malignancy, run by Incyte Corporation at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to 588 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.