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NCT03761095 · ClinicalTrials.gov registry record · Phase 1
A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)
A Phase 1 study of Leiomyosarcoma, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 4
- Study locations
NCT03761095 is a Phase 1 study of Leiomyosarcoma that has completed, run by PTC Therapeutics. The registered enrollment target is 41 participants, below the 119-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (66% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03761095, a Phase 1 study of Leiomyosarcoma, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 4
- Study locations
Study Summary
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 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.
Conditions Studied
Interventions
- DRUG Dacarbazine
- DRUG Unesbulin
Study Locations (4)
Florida
- Mayo Clinic Florida - Jacksonville
Maryland
- John Hopkins - Baltimore
Missouri
- Washington University Medical Campus - St Louis
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2024-02-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03761095
The ClinicalTrials.gov registry entry for NCT03761095 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (66% lower). The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Dacarbazine is the first listed.
NCT03761095 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Maryland, Missouri.
Frequently Asked Questions
What is clinical trial NCT03761095 about?
NCT03761095 is a clinical study titled "A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)". 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 w...
What is the current status of trial NCT03761095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-03-13. Estimated completion is 2024-02-05.
What conditions does trial NCT03761095 study?
This clinical trial studies the following conditions: Leiomyosarcoma.
What interventions are being tested in trial NCT03761095?
The interventions under investigation include: Dacarbazine (DRUG), Unesbulin (DRUG).
Who is sponsoring clinical trial NCT03761095?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03761095 being conducted?
This trial has 4 study locations across Florida, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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