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TAS1440 + ATRA for Leukemia
Study Summary
This trial will test a new drug, TAS1440, for safety and effectiveness in people with leukemia who have already tried other treatments that didn't work. The trial will last about 30 months.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a diagnosed condition.My bilirubin levels are high, or I have severe liver disease.I am not undergoing active treatment for a second cancer, except if it's breast or prostate cancer being managed with hormone therapy.I have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia.I have heart problems that significantly limit my daily activities.You have taken part in experimental treatment within two weeks before starting this study.My kidney function is within the normal range.I am taking a calcineurin inhibitor medication.My cancer did not respond to the initial standard chemotherapy.My condition did not improve after treatment with a specific medication.My white blood cell count is over 20,000 due to AML.My condition worsened after treatment with anthracycline, cytarabine, or a stem cell transplant.My doctor expects me to live at least 12 more weeks and I can complete a 4-week treatment cycle.My AML diagnosis is confirmed and all other treatments have failed.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant or breastfeeding and my pregnancy test was negative.I do not have an active, uncontrolled infection or have been stable on treatment for over 72 hours.I have severe graft versus host disease needing treatment.I do not have active HIV, HBV, or HCV, or if I do, it's under control with treatment.I am taking more than 5 mg/day of prednisone.You have a medical condition that could cause you to die soon.I cannot swallow pills.My leukemia is BCR-ABL positive.My leukemia has spread to my brain.You are allergic or sensitive to parabens.My liver is working well.You are allergic to ATRA or any other similar medication.I need more than 2 liters per minute of oxygen for a lung condition not related to AML.You have a mental illness or addiction that the researcher thinks might make it hard for you to follow the study rules.
- Group 1: TAS1440
- Group 2: TAS1440 + ATRA
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the Food and Drug Administration given its blessing to TAS1440?
"As this is a Phase 1 investigation, which implies limited evidence of safety and efficacy, the power team has given TAS1440 a score of 1 on the scale."
How many participants are being admitted to this clinical experiment?
"To ensure the success of this research, 80 volunteers who meet the required eligibility criteria are needed. Participants may enroll through University of Arizona Cancer Center Site#127 in Tucson or Fox Chase Cancer Center Site#112 in Philadelphia."
Could you provide a tally of the venues where this trial is supervised?
"For this trial, the University of Arizona Cancer Center Site#127 in Tucson, Arizona, Fox Chase Cancer Center Site#112 in Philadelphia and the University of Michigan Medical School in Seattle are amongst the 18 sites now enrolling."
For what purposes is TAS1440 typically employed?
"TAS1440 is a recommended treatment for severe, intractable cystic acne and related issues like dermal disorders, facial skin roughness, and sun protection regimens."
Does this research endeavor have any vacancies for participants?
"Affirmative, according to records hosted on clinicaltrials.gov this study is actively recruiting participants - it was first posted on March 15th 2020 and the most recent update occurred November 18th 2022. A total of 80 patients need to be enrolled from 17 different sites."
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