Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

Solid Tumors and Hematologic MalignancyAcute myeloid leukemia (AML)myelodysplastic syndrome (MDS)small cell lung cancer (SCLC)myelofibrosis (MF)solid tumor, lysine-specific demethylase 1 (LSD1) inhibitorNeoplasmsNivolumabAzacitidineTretinoinINCB059872all-trans retinoic acid (ATRA)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Moores UCSD Cancer Center accepting new patients
    La JollaCalifornia92093United States
  • UCLA Medical Center accepting new patients
    Los AngelesCalifornia90095United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02712905
Phase
Phase 1/2
Study Type
Interventional
Last Updated