TAS1440 + ATRA for Leukemia
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called TAS1440, alone and with ATRA, in patients with AML who didn't respond to previous treatments or whose cancer returned. It aims to see how the drug works in the body and if it can help treat the leukemia. Bisantrene, a new drug, has shown positive effects in earlier studies with manageable side effects.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on investigational therapy, you must stop it at least 2 weeks before starting the study treatment.
What data supports the effectiveness of the drug TAS1440 + ATRA for leukemia?
Research shows that all-trans retinoic acid (ATRA) has been effective in treating a specific type of leukemia called acute promyelocytic leukemia. However, its effectiveness in other types of leukemia, like nonacute promyelocytic acute myeloid leukemia, is less clear, with some studies suggesting limited benefit when used alone or in combination with other treatments.12345
Is the combination of TAS1440 and ATRA safe for humans?
The combination of all-trans retinoic acid (ATRA) with other drugs has been studied, and in one study, it was found to be safe with acceptable side effects like headache and heart rhythm changes. No serious toxicity was observed in another study when ATRA was combined with a different drug for leukemia treatment.26789
What makes the drug TAS1440 unique for treating leukemia?
TAS1440 is unique because it targets the ATR kinase, which is involved in DNA repair, making it effective against leukemia cells that are resistant to traditional therapies. This approach is particularly promising for leukemias with MLL rearrangements, which have a poor prognosis with standard treatments.39101112
Research Team
James Lowder, MD
Principal Investigator
Astex Pharmaceuticals, Inc.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
TAS1440 administered as a single agent once daily on specific days during each 28-day cycle
Treatment Part 2
TAS1440 administered once daily on specific days in combination with ATRA twice daily during each 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ATRA
- TAS1440
Find a Clinic Near You
Who Is Running the Clinical Trial?
Taiho Oncology, Inc.
Lead Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD
Astex Pharmaceuticals, Inc.
Lead Sponsor
Dr. Harren Jhoti
Astex Pharmaceuticals, Inc.
Chief Executive Officer since 2007
PhD in Biochemistry from Birkbeck College, London
Dr. Harold N. Keer
Astex Pharmaceuticals, Inc.
Chief Medical Officer since 2020
MD