← Back to Search

Anti-tumor antibiotic

Unesbulin + Dacarbazine for Leiomyosarcoma

Phase 1
Waitlist Available
Led By Brian Van Tine
Research Sponsored by PTC Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until the date of objectively documented progression per recist v1.1 or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 1.5 years)
Awards & highlights

Study Summary

This triallooks at safety and effectiveness of a new drug combo to treat a type of cancer.

Who is the study for?
Adults with advanced Leiomyosarcoma (LMS) who have normal liver and kidney function, controlled asthma or COPD, no more than four prior cancer treatments, and can swallow pills. They must not be pregnant, agree to use contraception if of childbearing potential, and cannot participate in other high-priority trials.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of Unesbulin combined with Dacarbazine in treating LMS. Participants will receive varying doses based on previous participants' reactions to find the maximum tolerated dose using a method called TITE-CRM.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding tendencies. Specific side effects related to Unesbulin are not detailed but may align with typical chemotherapy-related issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until the date of objectively documented progression per recist v1.1 or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 1.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until the date of objectively documented progression per recist v1.1 or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 1.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD and RP2D of Unesbulin in Combination With Dacarbazine
Number of Participants With Adverse Events
Secondary outcome measures
Accumulation Ratio (R) of Unesbulin, Dacarbazine, and Inactive Metabolite of Dacarbazine (AIC)
Dacarbazine
Dacarbazine
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Unesbulin and DacarbazineExperimental Treatment2 Interventions
Participants will receive unesbulin orally twice weekly in combination with dacarbazine IV once every 21 days. The first participant will receive dacarbazine 1000 mg/m^2 IV every 21 days in combination with unesbulin 200 mg tablet orally twice weekly. 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 DLT information from all participants previously treated. Participants will receive unesbulin 300 mg twice weekly in combination with dacarbazine in the expansion cohort. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unesbulin
2017
Completed Phase 1
~70
Dacarbazine
2005
Completed Phase 3
~5110

Find a Location

Who is running the clinical trial?

PTC TherapeuticsLead Sponsor
74 Previous Clinical Trials
6,189 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
360 Patients Enrolled for Leiomyosarcoma
Brian Van TinePrincipal InvestigatorWashington University Medical Campus
2 Previous Clinical Trials
213 Total Patients Enrolled
2 Trials studying Leiomyosarcoma
213 Patients Enrolled for Leiomyosarcoma
Christian MeyerPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
142 Total Patients Enrolled

Media Library

Dacarbazine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03761095 — Phase 1
Leiomyosarcoma Research Study Groups: Unesbulin and Dacarbazine
Leiomyosarcoma Clinical Trial 2023: Dacarbazine Highlights & Side Effects. Trial Name: NCT03761095 — Phase 1
Dacarbazine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03761095 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby May 2025