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.
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
Interventions
Drug | Synonyms | Arms |
---|
INCB059872 | | INCB059872 |
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
Name | Type | Description | Interventions |
---|
INCB059872 | Experimental | 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: | Terminated |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Relapsed Ewing sarcoma
- bromodomain-containing protein (BRD) inhibitor
- lysine demethylase 1 (LSD1) inhibitor
Last Updated
July 16, 2020