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

Status: Active

Description

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.

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.

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Kansas

Fairway
University of Kansas Clinical Research Center
Status: Active
Name Not Available
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCB 59872-101
Secondary IDs NCI-2016-00447
Clinicaltrials.gov ID NCT02712905