Back to resultsA Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
Primary Purpose
Relapsed Ewing Sarcoma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCB059872
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed Ewing Sarcoma focused on measuring Relapsed Ewing sarcoma, bromodomain-containing protein (BRD) inhibitor, lysine demethylase 1 (LSD1) inhibitor
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.
Sites / Locations
- UCLA Jonsson Comprehensive Cancer
- Mayo Clinic Jacksonville - PPDS
- Columbia University Medical Center
- St. Jude Children's Research Hospital
- MD Anderson Cancer Center
- Istituto Ortopedico Rizzoli
- Policlinico Sant'orsola-Malpighi
- Ospedale Pediatrico Bambino Gesu IRCCS
- Hospital Universitario Vall d'Hebron
- Hospital Clínico San Carlos
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INCB059872
Arm Description
INCB059872
Outcomes
Primary Outcome Measures
Number of adverse events
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
Objective response rate
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.
Cmax of INCB059872
Defined as maximum observed plasma concentration.
tmax of INCB059872
Defined as time to maximum concentration.
t½ of INCB059872
Defined as apparent terminal-phase disposition half-life.
Cl/F of INCB059872
Defined as apparent oral dose clearance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03514407
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Strategic Business Decision
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Ewing Sarcoma
Keywords
Relapsed Ewing sarcoma, bromodomain-containing protein (BRD) inhibitor, lysine demethylase 1 (LSD1) inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB059872
Arm Type
Experimental
Arm Description
INCB059872
Intervention Type
Drug
Intervention Name(s)
INCB059872
Intervention Description
Part 1: Initial cohort of INCB059872 administered every other day (QOD) at the protocol-defined starting dose, with subsequent cohort dose escalation based on protocol-defined criteria. Part 2: Expansion with the recommended dose from Part 1.
Primary Outcome Measure Information:
Title
Number of adverse events
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.
Time Frame
Screening through 30 days after last dose of study treatment, up to approximately 6 months.
Secondary Outcome Measure Information:
Title
Objective response rate
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.
Time Frame
Up to approximately 6 months.
Title
Cmax of INCB059872
Description
Defined as maximum observed plasma concentration.
Time Frame
Up to approximately 2 weeks.
Title
tmax of INCB059872
Description
Defined as time to maximum concentration.
Time Frame
Up to approximately 2 weeks.
Title
t½ of INCB059872
Description
Defined as apparent terminal-phase disposition half-life.
Time Frame
Up to approximately 2 weeks.
Title
Cl/F of INCB059872
Description
Defined as apparent oral dose clearance.
Time Frame
Up to approximately 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Zheng, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Jonsson Comprehensive Cancer
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Mayo Clinic Jacksonville - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Policlinico Sant'orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Pediatrico Bambino Gesu IRCCS
City
Rome
ZIP/Postal Code
00146
Country
Italy
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
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