Matches in SemOpenAlex for { <https://semopenalex.org/work/W4297995308> ?p ?o ?g. }
Showing items 1 to 86 of
86
with 100 items per page.
- W4297995308 endingPage "S1244" @default.
- W4297995308 startingPage "S1243" @default.
- W4297995308 abstract "Leiomyosarcoma (LMS) is one of the most common and aggressive subtypes of soft tissue sarcoma in adults, with the highest risk of recurrence and decreased disease-specific survival (George S, et al. J Clin Oncol. 2018; 36:144–150). A high unmet need remains for treatment of patients with unresectable or metastatic, relapsed or refractory LMS. In a Phase 1b study (NCT03761095), unesbulin, a microtubule polymerization inhibitor, plus dacarbazine (DTIC), was evaluated in patients with unresectable or metastatic, relapsed or refractory LMS, with acceptable benefit/risk ratio to support the start of a Phase 2/3 study. SUNRISELMS is an international, randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of unesbulin + DTIC versus placebo + DTIC in patients with unresectable or metastatic, relapsed or refractory LMS who received ≥1 prior line of systemic therapy. Patients will be randomized 2:1 to unesbulin 300 mg orally twice weekly (BIW) in each 3-week treatment cycle plus DTIC 1000 mg/m2 intravenous (IV) once every 21 days (Q21D). Matching oral placebo BIW plus DTIC IV 1000 mg/m2 will be administered Q21D. An interim analysis will be performed when ∼36%, or 88 of the progression-free survival (PFS) events occur. Eligible patients will have unresectable or metastatic, relapsed or refractory, measurable LMS according to RECIST 1.1, and be ≥18 years. Approximately 345 patients will be enrolled: 300 patients with 1 to 3 prior lines of systemic therapy for the primary analysis and 45 patients with at least 4 prior lines of systemic therapy for the exploratory interim analysis. Randomization will be stratified by histological tumor type (uterine versus nonuterine LMS), ECOG score of 0 or 1 and lines of treatment. The primary endpoint is PFS. Key secondary efficacy endpoints include overall survival, objective response rate, disease control rate, duration of response, and safety. The study is open and recruiting patients. NCT05269355. Medical writing assistance, supported financially by PTC Therapeutics, Inc., was provided by Ilaria Esposito, PhD of Lighthouse Medical Communications for preparation of this abstract. PTC Therapeutics, Inc. PTC Therapeutics, Inc." @default.
- W4297995308 created "2022-10-01" @default.
- W4297995308 creator A5002449470 @default.
- W4297995308 creator A5012166159 @default.
- W4297995308 creator A5025371306 @default.
- W4297995308 creator A5039846373 @default.
- W4297995308 creator A5041863599 @default.
- W4297995308 creator A5043221044 @default.
- W4297995308 creator A5043504754 @default.
- W4297995308 creator A5045230095 @default.
- W4297995308 creator A5077292025 @default.
- W4297995308 date "2022-09-01" @default.
- W4297995308 modified "2023-10-01" @default.
- W4297995308 title "1528TiP A phase II/III study evaluating the efficacy and safety of unesbulin in advanced leiomyosarcoma (SUNRISELMS)" @default.
- W4297995308 doi "https://doi.org/10.1016/j.annonc.2022.07.1917" @default.
- W4297995308 hasPublicationYear "2022" @default.
- W4297995308 type Work @default.
- W4297995308 citedByCount "0" @default.
- W4297995308 crossrefType "journal-article" @default.
- W4297995308 hasAuthorship W4297995308A5002449470 @default.
- W4297995308 hasAuthorship W4297995308A5012166159 @default.
- W4297995308 hasAuthorship W4297995308A5025371306 @default.
- W4297995308 hasAuthorship W4297995308A5039846373 @default.
- W4297995308 hasAuthorship W4297995308A5041863599 @default.
- W4297995308 hasAuthorship W4297995308A5043221044 @default.
- W4297995308 hasAuthorship W4297995308A5043504754 @default.
- W4297995308 hasAuthorship W4297995308A5045230095 @default.
- W4297995308 hasAuthorship W4297995308A5077292025 @default.
- W4297995308 hasBestOaLocation W42979953081 @default.
- W4297995308 hasConcept C121332964 @default.
- W4297995308 hasConcept C126322002 @default.
- W4297995308 hasConcept C136948725 @default.
- W4297995308 hasConcept C141071460 @default.
- W4297995308 hasConcept C142424586 @default.
- W4297995308 hasConcept C142724271 @default.
- W4297995308 hasConcept C143998085 @default.
- W4297995308 hasConcept C204787440 @default.
- W4297995308 hasConcept C27081682 @default.
- W4297995308 hasConcept C2776694085 @default.
- W4297995308 hasConcept C2777532014 @default.
- W4297995308 hasConcept C2778336483 @default.
- W4297995308 hasConcept C2778629024 @default.
- W4297995308 hasConcept C2780964509 @default.
- W4297995308 hasConcept C31760486 @default.
- W4297995308 hasConcept C535046627 @default.
- W4297995308 hasConcept C61943457 @default.
- W4297995308 hasConcept C71924100 @default.
- W4297995308 hasConcept C87355193 @default.
- W4297995308 hasConceptScore W4297995308C121332964 @default.
- W4297995308 hasConceptScore W4297995308C126322002 @default.
- W4297995308 hasConceptScore W4297995308C136948725 @default.
- W4297995308 hasConceptScore W4297995308C141071460 @default.
- W4297995308 hasConceptScore W4297995308C142424586 @default.
- W4297995308 hasConceptScore W4297995308C142724271 @default.
- W4297995308 hasConceptScore W4297995308C143998085 @default.
- W4297995308 hasConceptScore W4297995308C204787440 @default.
- W4297995308 hasConceptScore W4297995308C27081682 @default.
- W4297995308 hasConceptScore W4297995308C2776694085 @default.
- W4297995308 hasConceptScore W4297995308C2777532014 @default.
- W4297995308 hasConceptScore W4297995308C2778336483 @default.
- W4297995308 hasConceptScore W4297995308C2778629024 @default.
- W4297995308 hasConceptScore W4297995308C2780964509 @default.
- W4297995308 hasConceptScore W4297995308C31760486 @default.
- W4297995308 hasConceptScore W4297995308C535046627 @default.
- W4297995308 hasConceptScore W4297995308C61943457 @default.
- W4297995308 hasConceptScore W4297995308C71924100 @default.
- W4297995308 hasConceptScore W4297995308C87355193 @default.
- W4297995308 hasLocation W42979953081 @default.
- W4297995308 hasOpenAccess W4297995308 @default.
- W4297995308 hasPrimaryLocation W42979953081 @default.
- W4297995308 hasRelatedWork W2014391769 @default.
- W4297995308 hasRelatedWork W2058967569 @default.
- W4297995308 hasRelatedWork W2065332304 @default.
- W4297995308 hasRelatedWork W2118923225 @default.
- W4297995308 hasRelatedWork W2264927536 @default.
- W4297995308 hasRelatedWork W2267530785 @default.
- W4297995308 hasRelatedWork W2734824387 @default.
- W4297995308 hasRelatedWork W2888656831 @default.
- W4297995308 hasRelatedWork W3016178251 @default.
- W4297995308 hasRelatedWork W4297995308 @default.
- W4297995308 hasVolume "33" @default.
- W4297995308 isParatext "false" @default.
- W4297995308 isRetracted "false" @default.
- W4297995308 workType "article" @default.