A Study of TAS-120 in Patients With Advanced Solid Tumors

NCT02052778 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: TPU-TAS-120-1012013-004810-16
• Study Type: interventional
• Target: 407
• Locations: 13 countries
• Sites: 58

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, 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. 1.Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib.
2. 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. 3.Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)

  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; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.

  Cycle 1 (21-day cycle)

• Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120

  RP2D was MTD or less. MTD: Highest dose level at which \<33% of participants experience 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; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.

  Cycle 1 (21-day cycle)

• Phase 1: Dose Expansion: Percentage of Participants With Objective Response

  Objective response was defined as proportion of participants who had achieved best overall response of partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 millimeters (mm) and PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. For Cohorts 1 to 6: Objective response was based on Independent Review Committee (IRC) and for pooled Sub-cohort: Objective response was based on investigator review.

  Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts

• Phase 2: Percentage of Participants With Objective Response

  Objective response was defined as proportion of participants who had achieved best overall response of PR or CR per RECIST v1.1. CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 mm and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. The Phase 2 evaluation of objective response was based on central independent CT/MRI image assessment.

  Up to approximately 37.5 months (through cut-off date 29-May-2021)

Secondary Outcomes (17)

• Phase 1: Dose Expansion: Duration of Response (DOR)

  Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts

• Phase 2: Duration of Response (DOR)

  Up to approximately 37.5 months (through cut-off date 29-May-2021)

• Phase 1: Dose Expansion: Disease Control Rate (DCR)

  Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohort

• Phase 2: Disease Control Rate (DCR)

  Up to approximately 37.5 months (through cut-off date 29-May-2021)

• Phase 1: Dose Expansion: Progression-free Survival (PFS)

  up to approximately 27.5 months (through cut-off date 30-Jun-2019)

Study Arms (23)

Phase 1: Dose Escalation: QOD Dosing: 8 mg

EXPERIMENTAL

Participants with or without fibroblast growth factor \[FGF\]/fibroblast growth factor receptor \[FGFR\] gene abnormalities received orally TAS-120 8 milligrams (mg) orally every other day (QOD; Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 16 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 24 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 36 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 56 mg

EXPERIMENTAL

Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 80 mg

EXPERIMENTAL

Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 120 mg

EXPERIMENTAL

Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 160 mg

EXPERIMENTAL

Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QOD Dosing: 200 mg

EXPERIMENTAL

Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QD Dosing: 4 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QD Dosing: 8 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QD Dosing: 16 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QD Dosing: 20 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received a dose between 20 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Escalation: QD Dosing: 24 mg

EXPERIMENTAL

Participants with or without FGF/FGFR gene abnormalities received a dose between 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion Cohort 1

EXPERIMENTAL

Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion: Cohort 2

EXPERIMENTAL

Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion: Cohort 3

EXPERIMENTAL

Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion: Cohort 4

EXPERIMENTAL

Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1:Dose Expansion: Cohort 5

EXPERIMENTAL

Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion: Cohort 6

EXPERIMENTAL

Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion: Sub-cohort 1

EXPERIMENTAL

Participants with iCCA who were enrolled prior to the confirmation of the recommended Phase 2 dose (RP2D) received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 1: Dose Expansion: Sub-cohort 2

EXPERIMENTAL

Participants with other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Phase 2

EXPERIMENTAL

Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Drug: Futibatinib

Interventions

Futibatinib DRUG

oral once daily dosing, 21-day cycle

Also known as: TAS-120

Phase 1: Dose Escalation: QD Dosing: 16 mg; Phase 1: Dose Escalation: QD Dosing: 20 mg; Phase 1: Dose Escalation: QD Dosing: 24 mg; Phase 1: Dose Escalation: QD Dosing: 4 mg; Phase 1: Dose Escalation: QD Dosing: 8 mg; Phase 1: Dose Escalation: QOD Dosing: 120 mg; Phase 1: Dose Escalation: QOD Dosing: 16 mg; Phase 1: Dose Escalation: QOD Dosing: 160 mg; Phase 1: Dose Escalation: QOD Dosing: 200 mg; Phase 1: Dose Escalation: QOD Dosing: 24 mg; Phase 1: Dose Escalation: QOD Dosing: 36 mg; Phase 1: Dose Escalation: QOD Dosing: 56 mg; Phase 1: Dose Escalation: QOD Dosing: 8 mg; Phase 1: Dose Escalation: QOD Dosing: 80 mg; Phase 1: Dose Expansion Cohort 1; Phase 1: Dose Expansion: Cohort 2; Phase 1: Dose Expansion: Cohort 3; Phase 1: Dose Expansion: Cohort 4; Phase 1: Dose Expansion: Cohort 6; Phase 1: Dose Expansion: Sub-cohort 1; Phase 1: Dose Expansion: Sub-cohort 2; Phase 1:Dose Expansion: Cohort 5; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (58)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic (AZ)

Scottsdale, Arizona, 85259, United States

Location

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, 85719, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay

San Francisco, California, 94158, United States

Location

Cancer Treatment Centers of America

Newnan, Georgia, 30265, United States

Location

Cancer Treatment Centers of America Zion, IL

Zion, Illinois, 60099, United States

Location

The University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institution

Boston, Massachusetts, 02215, United States

Location

Wayne State Universtity (Karmanos Cancer Institute)

Detroit, Michigan, 48201, United States

Location

Mayo Clinic (MN)

Rochester, Minnesota, 55905, United States

Location

New Mexico Cancer Care Alliancer

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Sidney Kimmel Cancer Center at Jefferson

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Greenville Health System ITOR,Clinical Research Unit

Greenville, South Carolina, 29605, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Mary Crowley Cancer Research - Medical City

Dallas, Texas, 75230, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah, Huntsman Cancer Hospital

Salt Lake City, Utah, 84112, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

Location

Virginia Mason Cancer Center

Seattle, Washington, 98101, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Royal Melbourne Hospital

Melbourne, Australia

Location

Sunnybrook Research Institue

Toronto, M4N3M5, Canada

Location

Centre Léon Bérard Bât

Lyon, Cedex, 69373, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hospices Civils de Lyon

Bron, 69677, France

Location

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Rennes, Centre Eugène Marquis

Rennes, 35042, France

Location

Institute Goustave-Roussy-DITEP

Villejuif, 94805, France

Location

University Hospital Essen, West German Cancer Center, Department of Medical Oncology

Essen, 45147, Germany

Location

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS

Padua, 35128, Italy

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

Kyoto University Hospital, Department of Clinical Pharmacology and Therapeutics

Kyoto, 606-8507, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

University Hospital Jenna

Jenna, 07740, Netherlands

Location

Yonsei University, Severance Hospital (Seoul)

Seoul, 03722, South Korea

Location

ASAN Medical Center (Seoul)

Seoul, 05505, South Korea

Location

Samsung Medical Center (Seoul)

Seoul, 06351, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Val D'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona,

Barcelona, 08036, Spain

Location

University Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro

Madrid, Spain

Location

Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

University College London Hospital

London, W1T 7HA, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Publications (4)

• Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Komatsu Y, Ahn DH, Epstein RS, Halim AB, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Plain language summary of the FOENIX-CCA2 study: futibatinib for people with advanced bile duct cancer. Future Oncol. 2024;20(36):2811-2822. doi: 10.1080/14796694.2024.2364504. Epub 2024 Jun 17.

  PMID: 38884254 DERIVED

• DiPeri TP, Zhao M, Evans KW, Varadarajan K, Moss T, Scott S, Kahle MP, Byrnes CC, Chen H, Lee SS, Halim AB, Hirai H, Wacheck V, Kwong LN, Rodon J, Javle M, Meric-Bernstam F. Convergent MAPK pathway alterations mediate acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma. J Hepatol. 2024 Feb;80(2):322-334. doi: 10.1016/j.jhep.2023.10.041. Epub 2023 Nov 14.

  PMID: 37972659 DERIVED

• Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Mitchell EP, Komatsu Y, Masuda K, Ahn D, Epstein RS, Halim AB, Fu Y, Salimi T, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. doi: 10.1056/NEJMoa2206834.

  PMID: 36652354 DERIVED

• 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.

  PMID: 32622884 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma; Breast Neoplasms; Stomach Neoplasms

Interventions

futibatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Taiho
• Organization: Taiho Oncology, Inc.

medicalinformation@taihooncology.com

+1 844-878-2446

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: February 3, 2014
• Study Start: July 21, 2014
• Primary Completion: October 1, 2020
• Study Completion: October 22, 2024
• Last Updated: March 27, 2025
• Results First Posted: March 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); AU (1); FR (6); ES (4); DE (1); IT (2); US (26); HK (1); TW (2); GB (4); KR (4); JP (5); CA (1)