Phase 2
N=86
A Study of TAS-120 in Patients With Advanced Solid Tumors
Cholangiocarcinoma · Urothelial Cancer · Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors · Primary CNS Tumors · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02052778 ↗Enrolled (actual)
86
Serious AEs
43.5%
Results posted
Mar 2024
Primary outcome: Primary: Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD) — NA; 20 Milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Futibatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Taiho Oncology, Inc.
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD) |
NA; 20 | — |
| PRIMARY Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120 |
NA; 20 | — |
| PRIMARY Phase 1: Dose Expansion: Percentage of Participants With Objective Response |
15.8; 8.8; 13.3; 0; 12.5; 0 | — |
| PRIMARY Phase 2: Percentage of Participants With Objective Response |
41.7 | — |
| SECONDARY Phase 1: Dose Expansion: Duration of Response (DOR) |
6.18; 3.52; 2.45; 2.79; 8.77 | — |
| SECONDARY Phase 2: Duration of Response (DOR) |
8.31 | — |
| SECONDARY Phase 1: Dose Expansion: Disease Control Rate (DCR) |
66.7; 23.5; 33.3; 38.5; 54.2; 22.2 | — |
| SECONDARY Phase 2: Disease Control Rate (DCR) |
82.5 | — |
| SECONDARY Phase 1: Dose Expansion: Progression-free Survival (PFS) |
4.1; 1.9; 1.8; 1.3; 3.5; 2.7 | — |
| SECONDARY Phase 2: Progression-free Survival (PFS) |
8.9 | — |
| SECONDARY Phase 1: Dose Expansion: Overall Survival (OS) |
11.4; 11.8; 8.6; 5.8; 10.5; 7.2 | — |
| SECONDARY Phase 2: Overall Survival (OS) |
20.0 | — |
| SECONDARY Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits |
72; 18; 0; 60; 20; 1 | — |
| SECONDARY Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits |
82; 8; 0; 75; 6; 0 | — |
| SECONDARY Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits |
63; 24; 2; 47; 32; 2 | — |
| SECONDARY Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits |
42; 47; 1; 45; 35; 1 | — |
| SECONDARY Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Anxiety/Depression Scores at Specified Visits |
64; 25; 0; 66; 15; 0 | — |
| SECONDARY Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits |
71.72; -0.73; -1.04; -1.82; 0.40; 4.76 | — |
| SECONDARY Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints |
70.1; -1.0; 0.4; -0.5; 1.9; 0.9 | — |
| SECONDARY Phase 1: Dose Expansion: Number of Participants With Any Adverse Events (AEs) and Any Serious AEs (SAEs) |
57; 34; 15; 13; 23; 26 | — |
| SECONDARY Phase 2: Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) |
103; 42 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent
- Age ≥ 18 years of age
- Has histologically or cytologically confirmed, locally advanced or metastatic cancer
- The following specific criteria for each study portion
Phase 1 (Dose Escalation):
- Patients with any type of solid tumor
- Disease progression following standard therapies or intolerant to prior standard therapies
Phase 1 (Dose Expansion)
- Have at least one FGF/FGFR aberration
- Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
- Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or Response Assessment in Neuro-Oncology criteria (2010) for brain tumors.
- Patients with any of the following tumor types
- Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
- Patients with primary CNS tumors
- Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
- Patients with breast cancer or gastric cancer
- Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
- Patients with solid tumor types and other FGF/FGFR alterations not listed above
Phase 2
- Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
- Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
- Must have documentation of radiographic progression of disease
- No prior FGFR inhibitor
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function.
Exclusion Criteria
- History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
- History and/or current evidence of clinically significant ectopic mineralization/calcification.
- History and/or current evidence of clinically significant retinal disorder
- A serious illness or medical condition(s)
- Pregnant or breast-feeding female
Data sourced from ClinicalTrials.gov (NCT02052778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.