Myelodysplastic Syndrome Clinical Trial
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 11 Locations for this study
Birmingham Alabama, 35487, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Chicago Illinois, 60208, United States
Kansas City Kansas, 66045, United States
Buffalo New York, 14263, United States
New York New York, 10027, United States
Portland Oregon, 97297, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37240, United States
Houston Texas, 77030, United States
Brussel , , Belgium
Amsterdam , , Netherlands
Amsterdam , , Netherlands
Rotterdam , , Netherlands
How clear is this clinincal trial information?
