Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02965885 · ClinicalTrials.gov registry record · Phase 1
A Study of TAS-116 in Patients With Solid Tumors
A Phase 1 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02965885 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 31 participants.
The verdict
NCT02965885, a Phase 1 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.
Interventions
- DRUG TAS-116
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2019-05-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02965885
The ClinicalTrials.gov registry entry for NCT02965885 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TAS-116 is the first listed.
NCT02965885 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02965885 about?
NCT02965885 is a clinical study titled "A Study of TAS-116 in Patients With Solid Tumors". A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD...
What is the current status of trial NCT02965885?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2017-07-10. Estimated completion is 2019-05-03.
What interventions are being tested in trial NCT02965885?
The interventions under investigation include: TAS-116 (DRUG).
Who is sponsoring clinical trial NCT02965885?
This trial is sponsored by Taiho Oncology, which has 52 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.