NL-OMON53907
Not yet recruiting
Phase 2
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma - PTC596-ONC-008-LMS
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Leiomyosarcoma
- Sponsor
- PTC Therapeutics, Inc.
- Enrollment
- 10
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 5\. Male or female
- •Performance status: 6\. ECOG PS score of 0 or 1 Hematopoietic: 7\. Absolute
- •neutrophil count \>\=1500/mm3 without the use of growth factors in the past 7 days
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 antiarrhythmic therapy, or evidence of ischemia on
Outcomes
Primary Outcomes
Not specified
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