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A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

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ClinicalTrials.gov Identifier: NCT03514407
Recruitment Status : Terminated (Strategic Business Decision)
First Posted : May 2, 2018
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE June 27, 2018
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • 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.
  • Cmax of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as maximum observed plasma concentration.
  • tmax of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as time to maximum concentration.
  • t½ of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as apparent terminal-phase disposition half-life.
  • Cl/F of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as apparent oral dose clearance.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • 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.
  • Cmax of INCB059872 and INCB057643 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as maximum observed plasma concentration.
  • tmax of INCB059872 and INCB057643 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as time to maximum concentration.
  • t½ of INCB059872 and INCB057643 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as apparent terminal-phase disposition half-life.
  • Cl/F of INCB059872 and INCB057643 [ Time Frame: Up to approximately 2 weeks. ]
    Defined as apparent oral dose clearance.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
Official Title  ICMJE An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed Ewing Sarcoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: INCB059872
INCB059872
Intervention: Drug: INCB059872
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
42
Actual Study Completion Date  ICMJE June 25, 2020
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514407
Other Study ID Numbers  ICMJE INCB 59872-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fred Zheng, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP