Your session is about to expire
← 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 weeks3 visits
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)
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)
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 moreTrial 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
2019
Completed Phase 1
~50
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Both men and women can participate.Your cancer has spread to other parts of your body or is too advanced to be surgically removed.You can participate in the clinical trial if you have asthma or COPD, but only if your condition has been well-controlled. This means you have rarely needed to use medication for quick relief of symptoms or have not had any worsening of symptoms recently.
Research Study Groups:
This trial has the following groups:- Group 1: Unesbulin and Dacarbazine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger