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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Hematologic, Leukemia, Lung, Miscellaneous, Small Cell
Phase I/II
Mol. targeted/Immunotherapy/Biologics
Azacitidine, INCB059872, Nivolumab (BMS-936558), Tretinoin (ATRA)
Savona, Michael
Vanderbilt University


18 Years
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.

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