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Unesbulin
A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)
Ensayo de PTC THERAPEUTICS, INC. en Leiomyosarcoma (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 41
- Centros
- 4
- Fin del objetivo primario
- feb 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2019.
Qué mide
MTD and RP2D of Unesbulin in Combination With Dacarbazine (First 2 cycles of treatment (6 weeks)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of unesbulin in combination with dacarbazine for the treatment of advanced LMS and determine the overall safety profile of unesbulin in combination with dacarbazine. This study will employ the time-to-event continual reassessment method (TITE-CRM) for dose finding. Treatment will be initiated at dose level 2 (DL2) (Dacarbazine 1000 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] every 21 days in combination with unesbulin 200 milligrams \[mg\] orally twice weekly) for the first participant. This dose level represents the investigator's best assessment of the MTD based on available toxicity data for both agents. For subsequent participants, the dose level at which treatment is initiated will be selected based on the TITE-CRM using the most up to date dose-limiting toxicity (DLT) information from all participants previously treated. To enroll additional participants at the RP2D, the study is amended to include an expansion cohort of up to 12 participants (some of whom could be ongoing participants who reconsent). Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
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| PTC844 | Fase 2 | Aún sin reclutar | sep 2027 (prevista) |
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| Vatiquinone · PROVE-FA | Fase 3 | Aún sin reclutar | mar 2029 (prevista) |
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| PTC923 | Fase 3 | Completado | jul 2026 (real) |
Todos los de PTCT, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03761095), actualizada en mar 2024.