← Back to Search

Histone Deacetylase Inhibitor

TAS1440 + ATRA for Leukemia

Phase 1
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have disease that:
Have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 30 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) who have not responded to standard treatments or whose disease has returned. They should be in a condition stable enough to complete at least one treatment cycle, have an acceptable level of organ function, and women must not be pregnant or breastfeeding. People with certain heart conditions, active infections, other cancers needing treatment, or those unable to take oral medication cannot join.Check my eligibility
What is being tested?
The study is testing TAS1440 alone and combined with ATRA in people with relapsed/refractory AML. It aims to evaluate the safety and effectiveness of these treatments over approximately 30 months. Participants will receive TAS1440 as a single agent first then in combination with ATRA.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to the drugs, liver and kidney function changes, digestive issues due to oral intake of medication, possible heart complications from pre-existing conditions exacerbated by treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a diagnosed condition.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am not pregnant or breastfeeding and my pregnancy test was negative.
Select...
My kidney function is within the normal range.
Select...
My cancer did not respond to the initial standard chemotherapy.
Select...
My condition did not improve after treatment with a specific medication.
Select...
My condition worsened after treatment with anthracycline, cytarabine, or a stem cell transplant.
Select...
My AML diagnosis is confirmed and all other treatments have failed.
Select...
My doctor expects me to live at least 12 more weeks and I can complete a 4-week treatment cycle.
Select...
My liver is working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 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
Safety: Number of participants with treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Overall survival: Time from the date of the first dose until death due to any cause
Pharmacokinetic parameter: Area under the curve (AUC)
Pharmacokinetic parameter: Half-life (t1/2)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TAS1440 + ATRAExperimental Treatment1 Intervention
TAS1440 administered QD on specific days during each 28-day cycle in combination with ATRA twice daily (BID) in Part 2.
Group II: TAS1440Experimental Treatment1 Intervention
TAS1440 as a single agent administered once daily (QD) on specific days during each 28-day cycle in Part 1.

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,881 Total Patients Enrolled
James Lowder, MDStudy DirectorAstex Pharmaceuticals, Inc.
3 Previous Clinical Trials
227 Total Patients Enrolled

Media Library

TAS1440 (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04282668 — Phase 1
Acute Myeloid Leukemia Research Study Groups: TAS1440, TAS1440 + ATRA
Acute Myeloid Leukemia Clinical Trial 2023: TAS1440 Highlights & Side Effects. Trial Name: NCT04282668 — Phase 1
TAS1440 (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04282668 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

Has any prior research been conducted utilizing TAS1440?

"In 2006, Memorial Sloan Kettering Cancer Center was the first to initiate research into TAS1440. Since then, 90 trials have been completed with 21 ongoing studies being conducted out of Tucson, Arizona."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of TAS1440 With ATRA in Subjects With r/r AML
2020. "A Study of TAS1440 With ATRA in Subjects With r/r AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04282668.
~22 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top