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NCT02052778 · ClinicalTrials.gov registry record · Phase 1
A Study of TAS-120 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 407
- Enrollment target
NCT02052778 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 407 participants.
The verdict
NCT02052778, a Phase 1 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 407 participants
- Enrollment target
Study Summary
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Interventions
- DRUG Futibatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2014-07-21 |
| Est. Completion | 2024-10-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02052778
The ClinicalTrials.gov registry entry for NCT02052778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 407 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 Futibatinib is the first listed.
NCT02052778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02052778 about?
NCT02052778 is a clinical study titled "A Study of TAS-120 in Patients With Advanced Solid Tumors". This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced...
What is the current status of trial NCT02052778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 407 participants. The study started on 2014-07-21. Estimated completion is 2024-10-22.
What interventions are being tested in trial NCT02052778?
The interventions under investigation include: Futibatinib (DRUG).
Who is sponsoring clinical trial NCT02052778?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
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