Clinical Trials /

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

NCT02712905

Description:

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.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
  • Official Title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: INCB 59872-101
  • NCT ID: NCT02712905

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
INCB059872INCB059872

Purpose

This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 2 parts. Part 1 (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 dose(s).

Trial Arms

NameTypeDescriptionInterventions
INCB059872Experimental
  • INCB059872

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of INCB059872 as measured by the frequency, duration, and severity of adverse events (AEs) in participants, and determine recommended dose(s) for further study
Time Frame:AEs assessed from screening through 30 days after end of treatment, up to 6 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Tumor response rates in subjects with measurable disease
Time Frame:Tumor response at protocol-defined intervals from baseline through end of treatment, up to approximately 6 months
Safety Issue:
Description:
Measure:Maximum observed plasma concentration (Cmax) of INCB059872
Time Frame:0.5, 1, 2, 4, 6 hours postdose on Days 1 and 15 in treatment Cycle 1 and for food effect in Cycle 2, up to approximately 1 month
Safety Issue:
Description:
Measure:Area under the single-dose plasma concentration-time curve (AUC0-t) of INCB059872
Time Frame:0.5, 1, 2, 4, 6 hours postdose on Days 1 and 15 in treatment Cycle 1 and for food effect in Cycle 2, up to approximately 1 month
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Acute myeloid leukemia (AML)
  • myelodysplastic syndrome (MDS)
  • small cell lung cancer (SCLC)
  • myelofibrosis (MF)
  • solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor

Last Updated

April 10, 2017