Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Taiho Oncology.
NCT02052778 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 407 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (578% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
MTD:Highest dose level at which \<33% of participants experience dose-limiting toxicity (DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion;
Interventions
- DRUG Futibatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2014-07-21 |
| Est. Completion | 2024-10-22 |
| Phase | Phase 1 |
What the finished NCT02052778 record still lists
NCT02052778 is an interventional study that assigns participants to a tested intervention. The registered 407 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 (578% higher).
The record links to 0 conditions, and to 1 intervention - of which Futibatinib is the first listed.
NCT02052778 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02052778's enrollment target sits among peer trials
407 74th of 2000 higher than 1,927 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06735534 · 407 participants · NA
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
- NCT07094516 · 407 participants · Phase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
- NCT04835428 · 408 participants · NA
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
- NCT05836324 · 408 participants · Phase 1
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI