Clinical Trials /

A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

NCT03514407

Description:

The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.

Related Conditions:
  • Ewing Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
  • Official Title: An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma

Clinical Trial IDs

  • ORG STUDY ID: INCB 59872-103
  • NCT ID: NCT03514407

Conditions

  • Relapsed Ewing Sarcoma

Interventions

DrugSynonymsArms
INCB059872INCB059872

Purpose

The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.

Trial Arms

NameTypeDescriptionInterventions
INCB059872ExperimentalINCB059872
  • INCB059872

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have
             progressed on or after standard therapies.

          -  Must not be a candidate for potentially curative therapy or standard-of-care approved
             therapy.

          -  Measurable disease by computed tomography or magnetic resonance imaging based on
             RECIST 1.1 as determined by site radiology.

          -  Eastern Cooperative Oncology Group performance status 0 to 2.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Receipt of anticancer medications, anticancer therapies, or investigational drugs
             within protocol-defined intervals before the first administration of study drug.

          -  Must have recovered (≤ Grade 2 or at pretreatment baseline) from adverse events (AEs)
             from previously administered therapies except for stable chronic toxicities (≤ Grade
             2) not expected to resolve.

          -  Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases
             that have progressed.

          -  Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is
             permitted for palliative radiation to non-CNS disease with medical monitor approval.

          -  Laboratory values outside the protocol-defined range at screening.

          -  History or evidence of bleeding disorder or active clinically significant bleeding
             requiring medical intervention.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of adverse events
Time Frame:Screening through 30 days after last dose of study treatment, up to approximately 6 months.
Safety Issue:
Description:Defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a drug in humans, whether or not considered drug-related.

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:Up to approximately 6 months.
Safety Issue:
Description:Defined as the percentage of participants who have a complete response or partial response as determined by investigator assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measure:Cmax of INCB059872
Time Frame:Up to approximately 2 weeks.
Safety Issue:
Description:Defined as maximum observed plasma concentration.
Measure:tmax of INCB059872
Time Frame:Up to approximately 2 weeks.
Safety Issue:
Description:Defined as time to maximum concentration.
Measure:t½ of INCB059872
Time Frame:Up to approximately 2 weeks.
Safety Issue:
Description:Defined as apparent terminal-phase disposition half-life.
Measure:Cl/F of INCB059872
Time Frame:Up to approximately 2 weeks.
Safety Issue:
Description:Defined as apparent oral dose clearance.

Details

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

Trial Keywords

  • Relapsed Ewing sarcoma
  • bromodomain-containing protein (BRD) inhibitor
  • lysine demethylase 1 (LSD1) inhibitor

Last Updated

July 10, 2019