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ATR Inhibitor
ART0380 for Cancer (ARTIST Trial)
Phase 2
Recruiting
Research Sponsored by Artios Pharma Ltd
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 until disease progression (every 6 weeks from randomization upto 2 years)
Awards & highlights
ARTIST Trial Summary
This trial will study a new drug to see if it works and is safe for certain types of cancer.
Who is the study for?
This trial is for adults with certain types of advanced endometrial or solid tumors predicted to respond to ATR inhibition. Participants must have stopped previous cancer treatments, have good organ function, use effective contraception if childbearing potential exists, and not be pregnant. They should also have a life expectancy over 12 weeks and a performance status allowing daily activity.Check my eligibility
What is being tested?
The study tests ART0380 as a single therapy in patients selected based on their tumor biology's likelihood to respond well to blocking the ATR protein kinase. It aims to assess how effective and safe this treatment is for these specific cancers.See study design
What are the potential side effects?
While the side effects of ART0380 are not detailed here, similar drugs often cause fatigue, nausea, blood count changes, increased risk of infection due to immune system impact, liver function alterations, and potential allergic reactions.
ARTIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease progression (every 6 weeks from randomization upto 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression (every 6 weeks from randomization upto 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Area under the plasma concentration-time curve from zero to infinity (AUC0-inf)
Best overall response (BOR)
Change in tumor size
+7 moreARTIST Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 [ART0380 monotherapy (solid tumors patients)]Experimental Treatment1 Intervention
Patients with advanced or metastatic solid tumors will receive ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.
Group II: Arm 1 [ART0380 monotherapy (endometrial cancer patients)]Experimental Treatment1 Intervention
Patients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.
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Who is running the clinical trial?
Artios Pharma LtdLead Sponsor
5 Previous Clinical Trials
1,451 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- All side effects from my previous treatments have mostly gone away.My brain scans show no worsening after treatment for brain metastases.I have not had a severe bleeding episode or a bleeding disorder in the last 3 months.I am fully active or restricted in physically strenuous activity but can do light work.I am not taking strong drugs that affect liver enzymes within 2 weeks before starting the study treatment.I have not taken P-glycoprotein inhibitors, BCRP inhibitors, or statins in the last 2 weeks.I am allergic to some of the components in the study drug.I have serious stomach or intestine problems that could affect how I absorb medication.I have a lung condition that affects the tissue and space around the air sacs.I have advanced cancer and have tried PD-1/PD-L1 inhibitors if available for my cancer type.My organs are functioning well.I have a tumor sample that has not been exposed to radiation.I have been treated with specific inhibitors targeting cancer cell growth.I have endometrial cancer that has come back or didn't go away after treatment, and I've had or was supposed to have taxane/platinum chemotherapy.I stopped all cancer treatments at least 21 days ago, except for palliative radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 [ART0380 monotherapy (solid tumors patients)]
- Group 2: Arm 1 [ART0380 monotherapy (endometrial cancer patients)]
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved the usage of Arm 1 [ART0380 monotherapy (endometrial cancer patients)]?
"Based on our assessment, the safety of Arm 1 [ART0380 monotherapy (endometrial cancer patients)] is rated a 2. This is because there has been some evidence indicating its security profile yet no data demonstrating efficacy in clinical trials."
Answered by AI
What is the participant capacity for this trial?
"Artios Pharma Ltd is seeking to recruit 60 participants who meet the study's criteria across two trial sites: University of Oklahoma/Sarah Cannon Research Institute in Oklahoma City, and Women and Infants Hospital in Providence."
Answered by AI
Is this research experiment accepting new participants?
"Confirmed. According to the information stored on clinicaltrials.gov, this trial is still enrolling new patients since its initial posting date of September 7th 2023. To complete the study, 60 participants from 3 different medical centres are needed."
Answered by AI
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