TAS1440 for Acute Myeloid Leukemia

University of Michigan Medical School, Ann Arbor, MI
Acute Myeloid LeukemiaTAS1440 - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Approximately 30 months

Approximately 30 months
Overall survival: Time from the date of the first dose until death due to any cause
Response rate: Number of participants with complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial remission (PR) and complete remission with partial hematological recovery (CRh)
Safety: Number of participants with treatment-emergent adverse events (TEAEs)
Day 28
Pharmacokinetic parameter: Area under the curve (AUC)
Pharmacokinetic parameter: Half-life (t1/2)
Pharmacokinetic parameter: Maximum plasma concentration (Cmax)
Pharmacokinetic parameter: Minimum plasma concentration (Cmin)
Pharmacokinetic parameter: Time to reach maximum plasma concentration (Tmax)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Blinatumomab
1
KITE-222
1
CG-806

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

TAS1440
1 of 2
TAS1440 + ATRA
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: TAS1440 · No Placebo Group · Phase 1

TAS1440
Drug
Experimental Group · 1 Intervention: TAS1440 · Intervention Types: Drug
TAS1440 + ATRA
Drug
Experimental Group · 1 Intervention: TAS1440 + ATRA · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 30 months

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
93 Previous Clinical Trials
7,823 Total Patients Enrolled
James Lowder, MDStudy DirectorAstex Pharmaceuticals, Inc.
3 Previous Clinical Trials
227 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I apologize, but it seems like the criterion you provided is incomplete. Could you please provide me with the complete criterion so I can summarize it accurately?
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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