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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: Completed Phase 1 study, sponsored by Taiho Oncology.
NCT02965885 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02965885 record still lists
NCT02965885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which TAS-116 is the first listed.
NCT02965885 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02965885's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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