A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

Relapsed Ewing Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03514407
• Other study ID #: INCB 59872-103
• Status: Terminated
• Phase: Phase 1
• Start date: June 27, 2018
• Est. completion date: June 25, 2020

Study information

• Verified date: July 2020
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Relapsed Ewing Sarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Policlinico Sant'orsola-Malpighi	Bologna
Italy	Ospedale Pediatrico Bambino Gesu IRCCS	Rome
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
United Kingdom	The Christie NHS Foundation Trust	Manchester
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Jacksonville - PPDS	Jacksonville	Florida
United States	UCLA Jonsson Comprehensive Cancer	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening through 30 days after last dose of study treatment, up to approximately 6 months.
Secondary	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.	Up to approximately 6 months.
Secondary	Cmax of INCB059872	Defined as maximum observed plasma concentration.	Up to approximately 2 weeks.
Secondary	tmax of INCB059872	Defined as time to maximum concentration.	Up to approximately 2 weeks.
Secondary	t½ of INCB059872	Defined as apparent terminal-phase disposition half-life.	Up to approximately 2 weeks.
Secondary	Cl/F of INCB059872	Defined as apparent oral dose clearance.	Up to approximately 2 weeks.