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A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)

Completed · Phase 1 · NCT03761095

Conditions: Leiomyosarcoma

At a glance

Research payments reported, 2025
$233,153
U.S. investigators named
3
Sites paid
4
Planned or actual enrollment
41

About the trial

Sponsor
PTC Therapeutics
Tested
Unesbulin (drug), Dacarbazine (drug)
Dates
Started 2019-03-13; completion 2024-02-05
Results posted
Not yet

The 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 th…

From ClinicalTrials.gov, last updated 2024-03-15. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Ptc Therapeutics, Inc. reported $233,153 in research payments for this study in 2025 (11 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Mayo Clinic Jacksonville $108,060
  • The Trustees of Columbia University in The City of New York $79,107
  • Washington University $27,995
  • Johns Hopkins University $17,992

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.