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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 months
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 moreSide effects data
From 2015 Phase 3 trial • 55 Patients • NCT0212313471%
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
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
1,448 Previous Clinical Trials
2,531,486 Total Patients Enrolled
Benjamin Izar, MDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your disease is either inoperable or has spread to other parts of your body. If your disease can be removed surgically, but the risks of surgery are too high, you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: ATX-101
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.
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