A Study of PTC596 (Unesbulin) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)
Status:
Recruiting
Trial end date:
2021-12-29
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and
recommended phase 2 dose (RP2D) of PTC596 in combination with dacarbazine for the treatment
of advanced LMS and determine the overall safety profile of PTC596 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 PTC596 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.
Treatment will continue for each participant until evidence of unacceptable toxicity, disease
progression, or treatment discontinuation for another reason (study intervention
discontinuation and participant discontinuation/withdrawal).