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NCT02113813 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
NCT02113813: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT02113813 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 133 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02113813, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of ASP8273 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This study will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential inhibition of CYP3A4 by ASP8273 and the antitumor activity of ASP8273 as well as determine the effect of food on the bioavailability of ASP8273.
Primary Outcome
A DLT is defined as any pre-determined toxicity that is related to study drug per the investigator and which occurs during Cycle 0 and Cycle 1 using NCI CTCAE v4.03.
Interventions
- DRUG midazolam
- DRUG naquotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2014-04-09 |
| Est. Completion | 2019-02-11 |
| Phase | Phase 1 |
What the finished NCT02113813 record still lists
NCT02113813 is an interventional study that assigns participants to a tested intervention. The registered 133 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 (122% higher).
The record links to 0 conditions, and to 2 interventions - of which midazolam is the first listed.
NCT02113813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02113813 about?
NCT02113813 is a clinical study titled "A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations". The purpose of this study is to assess the safety and tolerability of ASP8273 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This study will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential inhibition of CYP3A4 by ASP8273 and the ...
What is the current status of trial NCT02113813?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2014-04-09. Estimated completion is 2019-02-11.
What interventions are being tested in trial NCT02113813?
The interventions under investigation include: midazolam (DRUG), naquotinib (DRUG).
Who is sponsoring clinical trial NCT02113813?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02113813's enrollment target sits among peer trials
133 432nd of 2000 higher than 1,569 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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