Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Leiomyosarcoma, sponsored by PTC Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD will be determined using the TITE-CRM for dose-finding. MTD is defined as the dose associated with a target probability of DLT of 0.25.
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 |
What the finished NCT03761095 record still lists
NCT03761095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 119-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (66% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Leiomyosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03761095's enrollment target sits among peer trials
41 8th of 16 higher than 9 of 16 other Leiomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
RECRUITING · Phase 1
-
Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma
ACTIVE NOT RECRUITING · Phase 1
-
LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma
COMPLETED · Phase 1
-
Localized Leiomyosarcoma Biomarker Protocol
RECRUITING
-
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
RECRUITING · Phase 3
-
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI