A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

Protocol: 
AAAQ7418
Phase: 
I/II

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

This study has two parts, the first part is called “dose escalation” (Part 1) and the second is “dose expansion” (Part 2). Dose Escalation (Part 1) Dose escalation is when a small set of subjects/research participants, called a cohort are given a specific dose of INCB059872. This small group is watched for 28 days. If the small group does well and tolerates the drug, then another small group is selected at a different dose, one that is usually higher. If certain side effects are observed at a given dose more subjects/research participants will be enrolled at that same dose so that these side effects can be evaluated further. In the dose-escalation part of the study approximately 24 subjects/research participants will be enrolled into one of the two treatment groups depending on the type of your cancer. Enrollment in this part of the study may continue until the highest dose that is safe and tolerated by the most subjects/research participants is found. T Dose Expansion (Part 2) Once a safe and tolerable dose of INCB059872 has been identified in the dose escalation part of the study, this part will enroll up to approximately 60 subjects/research participants into one of 4 different treatment groups (up to approximately 15 subjects/research participants for each group).

Are you Eligible? (Inclusion Criteria)

1. Male or female subjects, age 18 years or older.
2. Presence of measurable disease that has been confirmed by histology or cytology
3. The following malignancy types will be included in each of the treatment groups:
- AML or myelodysplastic syndrome (MDS)
- SCLC (other solid tumors, eg, endocrine tumors, are allowed with medical monitor approval)
- AML or MDS
- Myelofibrosis (MF)
- Other solid tumors (optional)

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States