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Experimental lymphoma drug ASTX660 tested in tiny, terminated trial

NCT ID NCT04362007

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the drug ASTX660 in just 8 people with T-cell lymphoma that had returned or not responded to prior treatments. The study aimed to find a safe dose and check for side effects, but it was stopped early. Because it was so small and incomplete, we cannot draw firm conclusions about whether ASTX660 works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ASTX660
What this could lead to
If it works, this could point toward a new treatment option for people with T-cell lymphoma that has not responded to other therapies.
What could go wrong
This was a very early, small trial that was terminated early, so we don't have enough data to know if ASTX660 is safe or effective. Many early-stage cancer drugs fail in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

8 people

The number who actually took part.

Started

Jul 2020

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017) 2. Patients with evaluable lesions. 3. Patients with ECOG PS score of 0 or 1. 4. Patients with adequate organ functions as shown below. * AST and ALT ≤ 2.0 × ULN (≤ 3.0 × ULN if liver infiltration is present) * Total bilirubin ≤ 1.5 × ULN * ANC ≥ 1,000/mm3 (≥ 750/mm3 if bone marrow infiltration is present) * Platelet count 50,000/mm3 (25,000/mm3 if bone marrow infiltration is present) * Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min * Amylase and lipase ≤ 1.0 × ULN Exclusion Criteria: 1. Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals 2. Patients with heart disease that meets the followings: 1. LVEF of \< 50% by echocardiography or MUGA scan 2. Congestive heart failure (NYHA classification III or IV) 3. Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days) 4. Complete left bundle branch block, III degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment 5. History or complication of long QT syndrome 6. History or complication of ventricular arrhythmia requiring active treatment 7. Corrected QT interval of ≥ 470 msec based on 12-lead ECG performed at the screening 8. Concern on increased cardiac risk by participating in the study based on medical judgment 3. Patients receiving the following treatment for the primary disease prior to the initial dose of study drug 1. Chemotherapy or radiotherapy within last 3 weeks 2. Skin directed therapy including local treatment or phototherapy within last 3 weeks 3. Treatment with monoclonal antibody within last 4 weeks 4. Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer 4. Patients with prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 14 weeks prior to the day of initial dose of study drug 5. Patients who have received corticosteroids at a dose exceeding a prednisone equivalent dose of 10 mg/day within 3 weeks prior to the initial dose of study drug. 6. Patients with Inadequately controlled diabetes mellitus

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yamagata University Hospital

    Yamagata, Japan

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Other studies related to the condition(s) this trial covers.