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

Status:	Recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/17/2019
Start Date:	May 2016
End Date:	March 2020
Contact:	Incyte Corporation Call Center
Phone:	1.855.463.3463

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability 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.

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.

We found this trial at

sites

Roswell Park Cancer Institute

666 Elm Street
Buffalo, New York 14263

(716) 845-2300