ATX-101 for Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Leiomyosarcoma+1 MoreATX-101 - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT02123134) in the ATX-101 (Deoxycholic Acid) Injection ARM group. Side effects include: Injection site pain with 71%, Injection site bruising with 71%, Injection site swelling with 61%, Injection site anaesthesia with 50%, Injection site nodule with 29%.

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: Drug
Treatment
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.