An Open-Label, Dose-Escalation / Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
Trial Status: Active
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.
- 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.
- 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.
University of Alabama at Birmingham Cancer Center
UCLA / Jonsson Comprehensive Cancer Center
University of California San Diego
University of Kansas Clinical Research Center
University of Kansas Cancer Center
University of Kansas Hospital-Westwood Cancer Center
Roswell Park Cancer Institute
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
University of Pennsylvania / Abramson Cancer Center
Vanderbilt University / Ingram Cancer Center
M D Anderson Cancer Center
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID INCB 59872-101
- Secondary IDs NCI-2016-00447
- Clinicaltrials.gov ID NCT02712905