TerminatedPhase 1

A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

United States68 participantsStarted 2020-06-12

Plain-language summary

To evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Have a projected life expectancy of at least 12 weeks, as assessed by the Investigator.
. Have histological confirmation of AML by World Health Organization (WHO) 2016 criteria and are either:
. refractory to intensive induction chemotherapy OR
. relapsed after intensive induction chemotherapy or stem cell transplant OR
. relapsed after or refractory to treatment with molecularly targeted and/or low-intensity chemotherapeutic regimens.
. Have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
. Have adequate renal function as demonstrated by measured or calculated creatinine clearance ≥60 mL/min.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Assessment: Number of participants with treatment-emergent adverse events (TEAEs)

Timeframe: Up to 30 months

Trial details

NCT IDNCT04155580

SponsorAstex Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-14

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Have a projected life expectancy of at least 12 weeks, as assessed by the Investigator.
. Have histological confirmation of AML by World Health Organization (WHO) 2016 criteria and are either:
. refractory to intensive induction chemotherapy OR
. relapsed after intensive induction chemotherapy or stem cell transplant OR
. relapsed after or refractory to treatment with molecularly targeted and/or low-intensity chemotherapeutic regimens.
. Have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
. Have adequate renal function as demonstrated by measured or calculated creatinine clearance ≥60 mL/min.

A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria