Study Summary
This trial is testing a new drug, ATX-101, to see if it's effective in treating two types of cancer, dedifferentiated liposarcoma (LPS) and leiomyosarcoma (LMS). ATX-101 is an IV drug that's thought to work by blocking the interaction of a protein called PCNA with other proteins involved in the stress response. This trial will see if ATX-101 can disrupt these interactions and help treat the cancer.
Eligible Conditions
- Leiomyosarcoma
- Liposarcoma
Video Summary
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Up to 3 years
12 weeks
Progression Free Rate (PFR)
Up to 3 years
Duration of the Response
Median Overall Survival (OS)
Median Progression Free Survival (PFS)
Number of Adverse Events
Objective Response Rate (ORR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
ATX-101 (Deoxycholic Acid) Injection
71%Injection site pain
71%Injection site bruising
61%Injection site swelling
50%Injection site anaesthesia
29%Injection site nodule
18%Injection site oedema
14%Injection site induration
14%Injection site erythema
7%Pain in jaw
7%Dysphonia
7%Skin tightness
4%Headache
Trial Design
1 Treatment Group
ATX-101
1 of 1
Experimental Treatment
34 Total Participants · 1 Treatment Group
Primary Treatment: ATX-101 · No Placebo Group · Phase 2
ATX-101
Drug
Experimental Group · 1 Intervention: ATX-101 · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deoxycholic acid
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,299 Previous Clinical Trials
1,620,503 Total Patients Enrolled
Matthew A. Ingham, MDPrincipal InvestigatorColumbia University
Eligibility Criteria
Age 18 - 99 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients must have measurable disease by RECIST criteria version 1.1.
You have a sarcoma.
Patients must have evidence of disease progression, either clinically or radiographically, within the 12 weeks prior to study enrollment, as determined by the investigator enrolling the patient on the study.
Patients must demonstrate an ECOG performance status of ≤2.
You have a locally advanced or metastatic disease and are eligible for this trial.
Patients must have been treated with at least one prior systemic regimen for advanced sarcoma: LMS: Anthracycline-based chemotherapy, or gemcitabine/docetaxel.
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Conditions
Cancer Related
Treatments