Back to resultsA Study of TAS-120 in Patients With Advanced Solid Tumors
Primary Purpose
Cholangiocarcinoma, Urothelial Cancer, Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Futibatinib
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring FGF, FGFR, Futibatinib, TAS-120
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 RANO 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
Sites / Locations
- Banner MD Anderson Cancer Center
- Mayo Clinic (AZ)
- The University of Arizona Cancer Center - North Campus
- City of Hope National Medical Center
- UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay
- Cancer Treatment Centers of America
- Cancer Treatment Centers of America Zion, IL
- The University of Kansas Cancer Center
- Massachusetts General Hospital
- Dana Farber Cancer Institution
- Wayne State Universtity (Karmanos Cancer Institute)
- Mayo Clinic (MN)
- New Mexico Cancer Care Alliancer
- Roswell Park Cancer Institute
- Hospital of the University of Pennsylvania
- Sidney Kimmel Cancer Center at Jefferson
- University of Pittsburgh Medical Center Hillman Cancer Center
- Greenville Health System ITOR,Clinical Research Unit
- Spartanburg Medical Center
- Mary Crowley Cancer Research - Medical City
- The University of Texas MD Anderson Cancer Center
- University of Utah, Huntsman Cancer Hospital
- University of Virginia Cancer Center
- Virginia Mason Cancer Center
- University of Wisconsin Clinical Science Center
- Medical College of Wisconsin
- Royal Melbourne Hospital
- Sunnybrook Research Institue
- Centre Léon Bérard Bât
- Institut Bergonie
- Hospices Civils de Lyon
- Pitié-Salpêtrière Hospital
- Rennes, Centre Eugène Marquis
- Institute Goustave-Roussy-DITEP
- University Hospital Essen, West German Cancer Center, Department of Medical Oncology
- The Chinese University of Hong Kong
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS
- Hokkaido University Hospital
- Kyoto University Hospital, Department of Clinical Pharmacology and Therapeutics
- Tohoku University Hospital
- Osaka International Cancer Institute
- National Cancer Center Hospital
- Yonsei University, Severance Hospital (Seoul)
- ASAN Medical Center (Seoul)
- Samsung Medical Center (Seoul)
- Seoul National University Hospital
- University Hospital Jenna
- Val D'Hebron University Hospital
- Hospital Clinic i Provincial de Barcelona,
- University Hospital Ramón y Cajal
- Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro
- Cheng Kung University Hospital
- National Taiwan University Hospital
- Guy's and St Thomas' NHS Foundation Trust
- Sarah Cannon Research Institute
- University College London Hospital
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Phase 1 Dose escalation
Phase 1 Dose expansion
Phase 2
Arm Description
Phase 1 Dose escalation portion for once daily and thrice weekly dosing of futibatinib (TAS-120) in patients with solid tumors.
Phase 1 Dose expansion portion for once daily dosing of futibatinib (TAS-120) in patients with tumors harboring FGF/FGFR aberrations
Phase 2 portion for once daily dosing of futibatinib (TAS-120) in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Outcomes
Primary Outcome Measures
Phase 1 (Dose escalation): Safety and Recommended Phase 2 Dose (RPTD)
Phase 1 (Dose expansion): Objective Response Rate (ORR)
Phase 2 - Objective Response Rate (ORR)
Objective Response Rate (ORR) by independent review committee according to RECIST guidelines (version 1.1, 2009)
Secondary Outcome Measures
Phase 1 (Dose escalation): Pharmacokinetics
Phase 1 (Dose escalation): Pharmacodynamics
Phase 1 (Dose escalation): - Anti-tumor activity: Objective Response Rate (ORR)
Phase 1 (Dose expansion): Safety
Phase 1 (Dose expansion): Disease Control Rate (DCR)
Phase 1 (Dose expansion): Duration of Response (DOR)
Phase 1 (Dose expansion): Progression free survival (PFS)
Phase 1 (Dose expansion): Overall survival (OS)
Phase 2: Duration of Response (DOR)
Phase 2: Safety
Phase 2: Disease Control Rate (DCR)
Phase 2: Progression free survival (PFS)
Phase 2: Overall survival (OS)
Phase 2: Patient Reported Outcome (PRO)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02052778
Brief Title
A Study of TAS-120 in Patients With Advanced Solid Tumors
Official Title
Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2014 (Actual)
Primary Completion Date
May 29, 2021 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, PK, 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:
Dose escalation portion to determine the MTD and/ or RP2D of futibatinib.
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 CNS tumors, urothelial carcinoma, breast cancer, gastric cancer.
Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Urothelial Cancer, Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors, Primary CNS Tumors, Breast Cancer, Gastric Cancer
Keywords
FGF, FGFR, Futibatinib, TAS-120
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
386 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 Dose escalation
Arm Type
Experimental
Arm Description
Phase 1 Dose escalation portion for once daily and thrice weekly dosing of futibatinib (TAS-120) in patients with solid tumors.
Arm Title
Phase 1 Dose expansion
Arm Type
Experimental
Arm Description
Phase 1 Dose expansion portion for once daily dosing of futibatinib (TAS-120) in patients with tumors harboring FGF/FGFR aberrations
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Phase 2 portion for once daily dosing of futibatinib (TAS-120) in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Intervention Type
Drug
Intervention Name(s)
Futibatinib
Other Intervention Name(s)
TAS-120
Intervention Description
oral once daily dosing, 21-day cycle
Primary Outcome Measure Information:
Title
Phase 1 (Dose escalation): Safety and Recommended Phase 2 Dose (RPTD)
Time Frame
Baseline until 30 days after end of study treatment; up to 18 months (estimated)
Title
Phase 1 (Dose expansion): Objective Response Rate (ORR)
Time Frame
Baseline to end of study treatment; up to 24 months (estimated)
Title
Phase 2 - Objective Response Rate (ORR)
Description
Objective Response Rate (ORR) by independent review committee according to RECIST guidelines (version 1.1, 2009)
Time Frame
Baseline to end of study treatment; up to 24 months (estimated)
Secondary Outcome Measure Information:
Title
Phase 1 (Dose escalation): Pharmacokinetics
Time Frame
Predose to Day 21 of cycle 1
Title
Phase 1 (Dose escalation): Pharmacodynamics
Time Frame
Predose to Day 21 of cycle 1
Title
Phase 1 (Dose escalation): - Anti-tumor activity: Objective Response Rate (ORR)
Time Frame
Baseline to end of study treatment; up to 24 months (estimated)
Title
Phase 1 (Dose expansion): Safety
Time Frame
Baseline until 30 days after end of study treatment; up to 24 months (estimated)
Title
Phase 1 (Dose expansion): Disease Control Rate (DCR)
Time Frame
Baseline to end of study treatment; up to 24 months (estimated)
Title
Phase 1 (Dose expansion): Duration of Response (DOR)
Time Frame
From onset to end of confirmed response; up to 24 months (estimated)
Title
Phase 1 (Dose expansion): Progression free survival (PFS)
Time Frame
Baseline until progressive disease or death; up to 24 months (estimated)
Title
Phase 1 (Dose expansion): Overall survival (OS)
Time Frame
Baseline until death; up to 36 months (estimated)
Title
Phase 2: Duration of Response (DOR)
Time Frame
From onset to end of confirmed response; up to 24 months (estimated)
Title
Phase 2: Safety
Time Frame
Baseline until 30 days after end of study treatment; up to 24 months (estimated)
Title
Phase 2: Disease Control Rate (DCR)
Time Frame
Baseline to end of study treatment; up to 24 months (estimated)
Title
Phase 2: Progression free survival (PFS)
Time Frame
Baseline until progressive disease or death; up to 24 months (estimated)
Title
Phase 2: Overall survival (OS)
Time Frame
Baseline until death; up to 36 months (estimated)
Title
Phase 2: Patient Reported Outcome (PRO)
Time Frame
Baseline until 30 days after end of study treatment; up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 RANO 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Benhadji, MD
Organizational Affiliation
Taiho Oncology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Mayo Clinic (AZ)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
The University of Arizona Cancer Center - North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Cancer Treatment Centers of America
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Cancer Treatment Centers of America Zion, IL
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State Universtity (Karmanos Cancer Institute)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic (MN)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New Mexico Cancer Care Alliancer
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sidney Kimmel Cancer Center at Jefferson
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Greenville Health System ITOR,Clinical Research Unit
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Mary Crowley Cancer Research - Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah, Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Mason Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Wisconsin Clinical Science Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Melbourne Hospital
City
Melbourne
Country
Australia
Facility Name
Sunnybrook Research Institue
City
Toronto
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Centre Léon Bérard Bât
City
Lyon
State/Province
Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Pitié-Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Rennes, Centre Eugène Marquis
City
Rennes cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Institute Goustave-Roussy-DITEP
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
University Hospital Essen, West German Cancer Center, Department of Medical Oncology
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Facility Name
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kyoto University Hospital, Department of Clinical Pharmacology and Therapeutics
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Yonsei University, Severance Hospital (Seoul)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
ASAN Medical Center (Seoul)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center (Seoul)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
University Hospital Jenna
City
Jenna
ZIP/Postal Code
07740
Country
Netherlands
Facility Name
Val D'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona,
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
University Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro
City
Madrid
Country
Spain
Facility Name
Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32622884
Citation
Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2.
Results Reference
derived
Learn more about this trial
A Study of TAS-120 in Patients With Advanced Solid Tumors
We'll reach out to this number within 24 hrs