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A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

Sponsor
Incyte Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT03514407
Collaborator
(none)
25
Enrollment
11
Locations
1
Arm
24
Actual Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
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 :
Jun 27, 2018
Actual Primary Completion Date :
Jun 25, 2020
Actual Study Completion Date :
Jun 25, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of adverse events [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 [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 [Up to approximately 2 weeks.]

    Defined as maximum observed plasma concentration.

  3. tmax of INCB059872 [Up to approximately 2 weeks.]

    Defined as time to maximum concentration.

  4. t½ of INCB059872 [Up to approximately 2 weeks.]

    Defined as apparent terminal-phase disposition half-life.

  5. Cl/F of INCB059872 [Up to approximately 2 weeks.]

    Defined as apparent oral dose clearance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Jonsson Comprehensive Cancer Los Angeles California United States 90095
2 Mayo Clinic Jacksonville - PPDS Jacksonville Florida United States 32224
3 Columbia University Medical Center New York New York United States 10032
4 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
5 MD Anderson Cancer Center Houston Texas United States 77030
6 Istituto Ortopedico Rizzoli Bologna Italy 40136
7 Policlinico Sant'orsola-Malpighi Bologna Italy 40138
8 Ospedale Pediatrico Bambino Gesu IRCCS Rome Italy 00146
9 Hospital Universitario Vall d'Hebron Barcelona Spain 08035
10 Hospital Clínico San Carlos Madrid Spain 28040
11 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX

Sponsors and Collaborators

  • Incyte Corporation

Investigators

  • Study Director: Fred Zheng, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03514407
Other Study ID Numbers:
  • INCB 59872-103
First Posted:
May 2, 2018
Last Update Posted:
Jul 16, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jul 16, 2020