A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

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

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
Relapsed Ewing Sarcoma	Drug: INCB059872	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: June 27, 2018
• Actual Primary Completion Date: June 25, 2020
• Actual Study Completion Date: June 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 [ 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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, California

UCLA Jonsson Comprehensive Cancer

Los Angeles, California, United States, 90095

United States, Florida

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, United States, 32224

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

United States, Tennessee

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Italy

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Policlinico Sant'orsola-Malpighi

Bologna, Italy, 40138

Ospedale Pediatrico Bambino Gesu IRCCS

Rome, Italy, 00146

Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain, 08035

Hospital Clínico San Carlos

Madrid, Spain, 28040

United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Incyte Corporation

Investigators

• Study Director: Fred Zheng, MD; Incyte Corporation

More Information

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT03514407
• Other Study ID Numbers: INCB 59872-103
• First Posted: May 2, 2018
• Last Update Posted: July 16, 2020
• Last Verified: July 2020

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