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NCT03520075 · ClinicalTrials.gov registry record · Phase 1
Study of ASTX029 in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 192
- Enrollment target
NCT03520075: Completed Phase 1 study, sponsored by Taiho Oncology.
NCT03520075 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 192 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (220% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03520075, a Phase 1 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 192 participants
- Enrollment target
Study Summary
This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to participants with advanced solid malignancies who are not candidates for approved or available therapies.
Primary Outcome
DLTs were defined as adverse events (AEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria that occurred during the first cycle of treatment and represented any 1 of the following: grade 4 thrombocytopenia of any duration; ≥grade 3 hematologic toxicity with complications (e.g., grade 3 thrombocytopenia with bleeding or transfusion requirement); febrile neutropenia of any duration or grade 4 neutropenia of 5 days or more duration; liv
Interventions
- DRUG ASTX029
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2025-03-03 |
| Phase | Phase 1 |
What the finished NCT03520075 record still lists
NCT03520075 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (220% higher).
The record links to 0 conditions, and to 1 intervention - of which ASTX029 is the first listed.
NCT03520075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03520075 about?
NCT03520075 is a clinical study titled "Study of ASTX029 in Subjects With Advanced Solid Tumors". This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to participants with advanced solid malignancies who are not candidates for approved or available therap...
What is the current status of trial NCT03520075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 192 participants. The study started on 2018-05-07. Estimated completion is 2025-03-03.
What interventions are being tested in trial NCT03520075?
The interventions under investigation include: ASTX029 (DRUG).
Who is sponsoring clinical trial NCT03520075?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03520075's enrollment target sits among peer trials
192 282nd of 2000 higher than 1,718 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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