Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 133 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02113813
The ClinicalTrials.gov registry entry for NCT02113813 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which midazolam is the first listed.
NCT02113813 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.