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PCNA inhibitor

ATX-101 for Liposarcoma (ATX-101 Trial)

Phase 2
Waitlist Available
Led By Benjamin Izar, MD
Research Sponsored by Benjamin Izar
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 up to approximately 7 months
Awards & highlights

ATX-101 Trial 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
  • Liposarcoma
  • Leiomyosarcoma

ATX-101 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Rate (PFR)
Secondary outcome measures
Duration of the Response
Median Overall Survival (OS)
Median Progression Free Survival (PFS)
+2 more

Side effects data

From 2015 Phase 3 trial • 55 Patients • NCT02123134
71%
Injection site bruising
71%
Injection site pain
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ATX-101 (Deoxycholic Acid) Injection

ATX-101 Trial Design

1Treatment groups
Experimental Treatment
Group I: ATX-101Experimental Treatment1 Intervention
Patients will be treated with ATX-101 60 mg/m2 IV weekly in continuous 21 day cycles. Patients will receive premedication prior to the ATX-101 infusion to reduce the risk of infusion-related reactions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATX-101
2008
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

Benjamin IzarLead Sponsor
Columbia UniversityLead Sponsor
1,437 Previous Clinical Trials
2,448,307 Total Patients Enrolled
Benjamin Izar, MDPrincipal InvestigatorColumbia University

Media Library

ATX-101 (PCNA inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05116683 — Phase 2
Liposarcoma Research Study Groups: ATX-101
Liposarcoma Clinical Trial 2023: ATX-101 Highlights & Side Effects. Trial Name: NCT05116683 — Phase 2
ATX-101 (PCNA inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116683 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ATX-101 been granted clearance by the Food and Drug Administration?

"Our team at Power assessed the safety of ATX-101 as a 2, due to it being in Phase 2. This means that while there is data available on its safety, no information has been collected yet regarding efficacy."

Answered by AI

What qualifications are necessary to be enrolled in this clinical experiment?

"34 individuals aged 18 to 99, with leiomyosarcoma and an ECOG performance status of ≤2 are eligible for this trial. Additionally, they must have received previous systemic treatment within the last 6 months that aligns with the type of sarcoma (LMS: Anthracycline-based chemotherapy or gemcitabine/docetaxel; LPS: No specification as to prior treatment). As safety data on ATX-101 in minors is unavailable, children cannot participate."

Answered by AI

Are there any relevant precedents involving ATX-101?

"ATX-101 is currently being studied by 4 active trials; none of these studies have entered Phase 3. South Brisbane, Queensland serves as the focal point for most research involving ATX-101 however it can also be found in 9 other locations around the world."

Answered by AI

Are there any age restrictions for participants of this research?

"This research endeavours to include participants aged 18 and above up until 99 years of age."

Answered by AI

Are there any available vacancies in this clinical research project?

"The data found on clinicaltrials.gov indicates that this research is still open for enrolment after being initially posted in the early days of November 2022 and recently updated near the end of the month."

Answered by AI

How many participants are eligible for involvement in this research endeavor?

"That is correct. The trial, which was initially published on 1st November 2022 and recently revised on 23rd November 2022, is actively recruiting 34 patients from one medical centre as per the details available on clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Columbia University Irving Medical Center / NewYork-Presbyterian
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
~1 spots leftby May 2025