Suspended

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

What is being tested

INCB059872

+ all-trans retinoic acid (ATRA)

+ azacitidine

Drug

Who is being recruted

Bone Marrow Diseases+18

+ Bronchial Neoplasms

+ Carcinoma, Bronchogenic

Over 18 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: May 2016

See protocol details

Summary

Principal SponsorIncyte Corporation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 5, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

NCT02712905

Principal SponsorIncyte Corporation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesBronchial NeoplasmsCarcinoma, BronchogenicHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidLung DiseasesLung NeoplasmsMyelodysplastic SyndromesMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLeukemia, Myeloid, AcuteHematologic NeoplasmsPrimary MyelofibrosisSmall Cell Lung Carcinoma

Criteria

4 inclusion criteria required to participate

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.

4 exclusion criteria prevent from participating

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

University of Alabama

Birmingham, United StatesOpen University of Alabama in Google Maps

Suspended

VU Medical Center

Amsterdam, Netherlands

Suspended

Moores UCSD Cancer Center

La Jolla, United States

Suspended

UCLA Medical Center

Los Angeles, United States

Suspended15 Study Centers