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Clinical Trials/EUCTR2022-000073-12-ES
EUCTR2022-000073-12-ES
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

PTC Therapeutics, Inc.0 sites345 target enrollmentApril 18, 2022
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ConditionseiomyosarcomaMedDRA version: 20.0Level: HLTClassification code 10024190Term: LeiomyosarcomasSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
eiomyosarcoma
Sponsor
PTC Therapeutics, Inc.
Enrollment
345
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 18, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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