A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) (NCT05269355) | Clinical Trial Compass
TerminatedPhase 2/3
A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
Stopped: Business decision
United States359 participantsStarted 2022-05-23
Plain-language summary
This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Histological or cytological confirmation of LMS arising at any anatomic site except bone sarcoma, unresectable or metastatic, relapsed or refractory disease measurable per RECIST 1.1 criteria
* Disease progression on previous treatment before screening or intolerability to other oncology treatments
* Participants with liver metastases may be enrolled
* Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled.
* Toxicity from prior therapies recovered to Grade ≤1 or participant's baseline, except for alopecia. In addition, endocrinopathies associated with prior immunotherapy-based treatments that are well controlled on replacement medication are not exclusionary.
* At least 1 prior systemic cytotoxic or targeted therapy regimen for LMS, which may include but is not limited to single-agent doxorubicin or other anthracycline, doxorubicin plus ifosfamide, trabectedin, pazopanib, or gemcitabine with or without docetaxel.
* At least 4 weeks since prior surgery and recovered in the opinion of investigator
Key Exclusion Criteria:
* Received temozolomide or dacarbazine at any time
* Any other systemic anticancer therapy including investigational agents ≤3 weeks before initiation of study treatment. Additionally, participants may not have received radiation ≤3 weeks before initiation of study treatment.
* Known intolerance to dacarbazine or one or more of the excipients in unesbulin.
* Co-existing active infection or…
What they're measuring
1
Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1