Trial · NCT04362007
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
NCT04362007, Phase 1, Phase 2, Terminated, Otsuka Pharmaceutical Co., Ltd.; results first posted 2026-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma. Trials, record NCT04362007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04362007
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma
- NCT number
- NCT04362007
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Relapsed or Refractory Peripheral T-cell Lymphoma(PTCL),Cutaneous T-cell Lymphoma(CTCL),Adult T-cell Leukemia/Lymphoma(ATLL)
- Interventions
- ASTX660, ASTX660, ASTX660
- First posted
- 2020-04-24
- Last updated
- 2026-02-25
- Results first posted
- 2026-02-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results | 28 days (Day1 to Day29) | Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours |
| Secondary | Pharmacokinetic Outcome of Concentration-time Curve (AUC) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC). |
| Secondary | Pharmacokinetic Outcome of Maximum Concentration (Cmax) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | Assessment of pharmacokinetic parameter maximum concentration (Cmax). |
| Secondary | Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | Assessment of pharmacokinetic parameter time to maximum concentration (Tmax). |
| Secondary | Pharmacokinetic Outcome of Elimination Half Life (t½) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | Assessment of pharmacokinetic parameter elimination half life (t½). |
| Secondary | Pharmacokinetic Outcome of Clearance of Drug From Plasma | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | Assessment of pharmacokinetic parameter clearance of drug from plasma. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results | 28 days (Day1 to Day29) | The DLT analysis population include all subjects who received at least 1 dose of IMP and have available data necessary for DLT assessment during the DLT assessment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic Outcome of Concentration-time Curve (AUC) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point. | ng∙h/mL | MEAN |
| SECONDARY | Pharmacokinetic Outcome of Maximum Concentration (Cmax) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point. | h | MEDIAN |
| SECONDARY | Pharmacokinetic Outcome of Elimination Half Life (t½) | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point. | h | MEAN |
| SECONDARY | Pharmacokinetic Outcome of Clearance of Drug From Plasma | Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose | PK analysis population included subjects who received at least 1 dose of IMP and had available ASTX660 concentration measurement data for at least 1 time point. | L/h | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results | Cohort 1 | 1 | Participants | ||
| Pharmacokinetic Outcome of Concentration-time Curve (AUC) | Cohort 1 | Day 1 | 1280 | Standard Deviation 915 | ng∙h/mL |
| Pharmacokinetic Outcome of Concentration-time Curve (AUC) | Cohort 2 | Day 1 | 2020 | ng∙h/mL | |
| Pharmacokinetic Outcome of Concentration-time Curve (AUC) | Cohort 1 | Day 7 | 2410 | Standard Deviation 1410 | ng∙h/mL |
| Pharmacokinetic Outcome of Maximum Concentration (Cmax) | Cohort 1 | Day 1 | 249 | Standard Deviation 135 | ng/mL |
| Pharmacokinetic Outcome of Maximum Concentration (Cmax) | Cohort 2 | Day 1 | 405 | ng/mL | |
| Pharmacokinetic Outcome of Maximum Concentration (Cmax) | Cohort 1 | Day 7 | 380 | Standard Deviation 180 | ng/mL |
| Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax) | Cohort 1 | Day 1 | 0.98 | Full Range 0.50 to 3.00 | h |
| Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax) | Cohort 2 | Day 1 | 0.48 | Full Range 0.48 to 0.48 | h |
| Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax) | Cohort 1 | Day 7 | 0.94 | Full Range 0.42 to 2.98 | h |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 2 | 1 | |
| Overall Study | STARTED | Cohort 1 | 7 | |
| Overall Study | COMPLETED | Cohort 2 | 0 | |
| Overall Study | COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 1 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 7 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 0 | 1 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1 | 3 | 7 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2 | 0 | 1 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 | 1 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2 | 0 | 1 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 | 1 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2 | 0 | 1 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1 | 1 | 7 | |
| other | Constipation | Gastrointestinal disorders | Cohort 2 | 0 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 7 |
| Total, all-cause mortality | Cohort 2 | 0 | 1 |
| Total, other adverse events | Cohort 1 | 7 | 7 |
| Total, other adverse events | Cohort 2 | 1 | 1 |
| Total, serious adverse events | Cohort 1 | 0 | 7 |
| Total, serious adverse events | Cohort 2 | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04362007
GET https://conductscience.org/api/trials/v1/NCT04362007/events?page=2