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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
No Placebo-Only Group
Summary
This trial is testing a new IV drug called ATX-101 for patients with specific types of cancer (LPS and LMS) who haven't had success with other treatments. ATX-101 blocks a protein interaction that helps cancer cells survive, potentially making it an effective treatment option.
Eligible Conditions
- Liposarcoma
- Leiomyosarcoma
- Soft Tissue 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Rate (PFR)
Secondary study objectives
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 pain
71%
Injection site bruising
61%
Injection site swelling
50%
Injection site anaesthesia
29%
Injection site nodule
18%
Injection site oedema
14%
Injection site erythema
14%
Injection site induration
7%
Skin tightness
7%
Dysphonia
7%
Pain in jaw
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ATX-101 (Deoxycholic Acid) Injection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Benjamin IzarLead Sponsor
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,335 Total Patients Enrolled
1 Trials studying Liposarcoma
29 Patients Enrolled for Liposarcoma
Benjamin Izar, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Liposarcoma
29 Patients Enrolled for Liposarcoma
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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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