EUCTR2022-000073-12-HU
Active, not recruiting
Phase 1
A PHASE 2/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UNESBULIN IN UNRESECTABLE OR METASTATIC, RELAPSED OR REFRACTORY LEIOMYOSARCOMA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- eiomyosarcoma
- Sponsor
- PTC Therapeutics, Inc.
- Enrollment
- 345
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1\. Subject is willing and able to provide informed consent
- •2\. Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
- •3\. Disease status including:
- •a. Histological or cytological confirmation of LMS arising at any anatomic site except bone sarcoma
- •b. Unresectable or metastatic, relapsed or refractory disease
- •c. Measurable disease per RECIST 1\.1 criteria
- •d. Disease progression on previous treatment before screening or intolerability to other oncology treatments
- •Demographics:
- •4\. Age \=18 years
Exclusion Criteria
- •1\. Received temozolomide or DTIC at any time
- •2\. Any other systemic anticancer therapy including investigational agents \=3 weeks before initiation of study treatment. Additionally, subjects may not have received radiation \=3 weeks before initiation of study treatment.
- •3\. Known intolerance to DTIC or one or more of the excipients in unesbulin.
- •4\. Co\-existing active infection or any co\-existing medical condition likely to interfere with study procedures, including:
- •a. Significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring therapy, unstable arrhythmia or a need for anti\-arrhythmic therapy, or evidence of ischemia on ECG, marked baseline prolongation of QT/QTc (corrected QT) interval, eg, repeated demonstration of a QTc interval \>500 msec (Long QT Syndrome \[congenital])
- •5\. Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus positivity
- •6\. History of solid organ transplantation
- •Therapeutics:
- •7\. Known or suspected allergy or immediate or delayed hypersensitivity to unesbulin or dacarbazine, their excipients, or any agent given in this study
- •Gastrointestinal:
Outcomes
Primary Outcomes
Not specified
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