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An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Primary Purpose

Solid Tumors and Hematologic Malignancy

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCB059872
all-trans retinoic acid (ATRA)
azacitidine
nivolumab
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors and Hematologic Malignancy focused on measuring Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), small cell lung cancer (SCLC), myelofibrosis (MF), solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Alabama
  • Moores UCSD Cancer Center
  • UCLA Medical Center
  • Northwestern University
  • University of Kansas Center for Research, Inc.
  • Roswell Park Cancer Institute
  • Columbia University
  • Oregon Health Science University
  • University of Pennsylvania
  • Vanderbilt University
  • University of Texas MD Anderson Cancer Center
  • Institut Jules Bordet
  • Netherland Cancer Institute
  • VU Medical Center
  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

INCB059872

INCB059872 in combination with other therapies

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Cmax of INCB059872 in Plasma When Received as Monotherapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Tmax of INCB059872 in Plasma When Received as Monotherapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
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.
t1/2 of INCB059872 in Plasma When Received as Monotherapy
t1/2 was defined as the half-life of INCB059872.
CL/F of INCB059872 in Plasma When Received as Monotherapy
CL/F was defined as the apparent oral clearance of INCB059872.
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.
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.
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.
Cmax of INCB059872 in Plasma When Received as Combination Therapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Tmax of INCB059872 in Plasma When Received as Combination Therapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
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.
t1/2 of INCB059872 in Plasma When Received as Combination Therapy
t1/2 was defined as the half-life of INCB059872.
CL/F of INCB059872 in Plasma When Received as Combination Therapy
CL/F was defined as the apparent oral clearance of INCB059872.

Full Information

First Posted
February 18, 2016
Last Updated
May 15, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02712905
Brief Title
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
Official Title
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic Business Decision
Study Start Date
May 5, 2016 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INCB059872
Arm Type
Experimental
Arm Title
INCB059872 in combination with other therapies
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
INCB059872
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
all-trans retinoic acid (ATRA)
Intervention Type
Drug
Intervention Name(s)
azacitidine
Intervention Type
Drug
Intervention Name(s)
nivolumab
Primary Outcome Measure Information:
Title
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)
Description
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.
Time Frame
up to 588 days
Title
Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE
Description
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.
Time Frame
up to 1387 days
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy
Description
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.
Time Frame
up to 518 days
Title
ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy
Description
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.
Time Frame
up to 85 days
Title
ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy
Description
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.
Time Frame
up to 61 days
Title
Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy
Description
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.
Time Frame
Baseline; Week 12
Title
Cmax of INCB059872 in Plasma When Received as Monotherapy
Description
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
Tmax of INCB059872 in Plasma When Received as Monotherapy
Description
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy
Description
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.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
t1/2 of INCB059872 in Plasma When Received as Monotherapy
Description
t1/2 was defined as the half-life of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
CL/F of INCB059872 in Plasma When Received as Monotherapy
Description
CL/F was defined as the apparent oral clearance of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
ORR in Participants With SCLC Who Received Combination Therapy
Description
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.
Time Frame
up to 1353 days
Title
ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy
Description
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.
Time Frame
up to 208 days
Title
ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy
Description
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.
Time Frame
up to 85 days
Title
Cmax of INCB059872 in Plasma When Received as Combination Therapy
Description
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
Tmax of INCB059872 in Plasma When Received as Combination Therapy
Description
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy
Description
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.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
t1/2 of INCB059872 in Plasma When Received as Combination Therapy
Description
t1/2 was defined as the half-life of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Title
CL/F of INCB059872 in Plasma When Received as Combination Therapy
Description
CL/F was defined as the apparent oral clearance of INCB059872.
Time Frame
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Zheng, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
University of Kansas Center for Research, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97297
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Institut Jules Bordet
City
Brussel
Country
Belgium
Facility Name
Netherland Cancer Institute
City
Amsterdam
Country
Netherlands
Facility Name
VU Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

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