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

a study on Solid Tumor

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