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A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

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ClinicalTrials.gov Identifier: NCT03514407
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Relapsed Ewing Sarcoma Drug: INCB059872 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: INCB059872
INCB059872
Drug: INCB059872
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 Measures :
  1. Number of adverse events [ Time Frame: Screening through 30 days after last dose of study treatment, up to approximately 6 months. ]
    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 :
  1. Objective response rate [ Time Frame: Up to approximately 6 months. ]
    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.

  2. Cmax of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as maximum observed plasma concentration.

  3. tmax of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as time to maximum concentration.

  4. t½ of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as apparent terminal-phase disposition half-life.

  5. Cl/F of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as apparent oral dose clearance.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514407


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
United States, California
UCLA Jonsson Comprehensive Cancer Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Noah Federman         
United States, Florida
Mayo Clinic Jacksonville - PPDS Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Steven Attia         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Gary Schwartz         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Principal Investigator: Alberto Pappo         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Vivek Subbiah         
Italy
Ospedale Pediatrico Bambino Gesu IRCCS Not yet recruiting
Bologna, Italy, 00146
Principal Investigator: Giuseppe Milano         
Policlinico Sant'orsola-Malpighi Not yet recruiting
Bologna, Italy, 40138
Principal Investigator: Stefania Salvagni         
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Claudia Valverde Morales         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Principal Investigator: Antonio Casado         
United Kingdom
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Martin McCabe         
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Fred Zheng, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03514407     History of Changes
Other Study ID Numbers: INCB 59872-103
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Relapsed Ewing sarcoma
bromodomain-containing protein (BRD) inhibitor
lysine demethylase 1 (LSD1) inhibitor

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue