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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03514407
Other study ID # INCB 59872-103
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Recruiting NCT05734066 - Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma Phase 1/Phase 2
Completed NCT02546544 - Eurosarc Trial of Linsitinib in Advanced Ewing Sarcoma Phase 2
Completed NCT04661852 - Cabozantinib With Topotecan-Cyclophosphamide Phase 1
Active, not recruiting NCT03635632 - C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N) Phase 1