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
Verified date | July 2020 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Italy, Spain, United Kingdom,
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. |
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