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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02052778
Recruitment Status : Active, not recruiting
First Posted : February 3, 2014
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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:

  1. Dose escalation portion to determine the MTD and/ or RP2D 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 CNS tumors, urothelial carcinoma, breast cancer, gastric cancer.
  3. Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Urothelial Cancer Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors Primary CNS Tumors Breast Cancer Gastric Cancer Drug: Futibatinib Phase 1 Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations
Actual Study Start Date : July 2014
Actual Primary Completion Date : May 29, 2021
Estimated Study Completion Date : June 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1 Dose escalation
Phase 1 Dose escalation portion for once daily and thrice weekly dosing of futibatinib (TAS-120) in patients with solid tumors.
 Drug: Futibatinib
oral once daily dosing, 21-day cycle
Other Name: TAS-120
Experimental: Phase 1 Dose expansion
Phase 1 Dose expansion portion for once daily dosing of futibatinib (TAS-120) in patients with tumors harboring FGF/FGFR aberrations
 Drug: Futibatinib
oral once daily dosing, 21-day cycle
Other Name: TAS-120
Experimental: Phase 2
Phase 2 portion for once daily dosing of futibatinib (TAS-120) in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
 Drug: Futibatinib
oral once daily dosing, 21-day cycle
Other Name: TAS-120


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. Phase 1 (Dose expansion): Objective Response Rate (ORR) [ Time Frame: Baseline to end of study treatment; up to 24 months (estimated) ]
  3. Phase 2 - Objective Response Rate (ORR) [ Time Frame: Baseline to end of study treatment; up to 24 months (estimated) ]
    Objective Response Rate (ORR) by independent review committee according to RECIST guidelines (version 1.1, 2009)


Secondary Outcome Measures :
  1. Phase 1 (Dose escalation): Pharmacokinetics [ Time Frame: Predose to Day 21 of cycle 1 ]
  2. Phase 1 (Dose escalation): Pharmacodynamics [ Time Frame: Predose to Day 21 of cycle 1 ]
  3. Phase 1 (Dose escalation): - Anti-tumor activity: Objective Response Rate (ORR) [ Time Frame: Baseline to end of study treatment; up to 24 months (estimated) ]
  4. Phase 1 (Dose expansion): Safety [ Time Frame: Baseline until 30 days after end of study treatment; up to 24 months (estimated) ]
  5. Phase 1 (Dose expansion): Disease Control Rate (DCR) [ Time Frame: Baseline to end of study treatment; up to 24 months (estimated) ]
  6. Phase 1 (Dose expansion): Duration of Response (DOR) [ Time Frame: From onset to end of confirmed response; up to 24 months (estimated) ]
  7. Phase 1 (Dose expansion): Progression free survival (PFS) [ Time Frame: Baseline until progressive disease or death; up to 24 months (estimated) ]
  8. Phase 1 (Dose expansion): Overall survival (OS) [ Time Frame: Baseline until death; up to 36 months (estimated) ]
  9. Phase 2: Duration of Response (DOR) [ Time Frame: From onset to end of confirmed response; up to 24 months (estimated) ]
  10. Phase 2: Safety [ Time Frame: Baseline until 30 days after end of study treatment; up to 24 months (estimated) ]
  11. Phase 2: Disease Control Rate (DCR) [ Time Frame: Baseline to end of study treatment; up to 24 months (estimated) ]
  12. Phase 2: Progression free survival (PFS) [ Time Frame: Baseline until progressive disease or death; up to 24 months (estimated) ]
  13. Phase 2: Overall survival (OS) [ Time Frame: Baseline until death; up to 36 months (estimated) ]
  14. Phase 2: Patient Reported Outcome (PRO) [ Time Frame: Baseline until 30 days after end of study treatment; up to 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent
  2. Age ≥ 18 years of age
  3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer

  4. 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)
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Adequate organ function.

Exclusion Criteria:

  1. History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
  2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
  3. History and/or current evidence of clinically significant retinal disorder
  4. A serious illness or medical condition(s)
  5. Pregnant or breast-feeding female
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052778


Locations
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Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
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Study Director: Karim Benhadji, MD Taiho Oncology, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02052778    
Other Study ID Numbers: TPU-TAS-120-101
2013-004810-16 ( EudraCT Number )
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
FGF
FGFR
Futibatinib
TAS-120
Additional relevant MeSH terms:
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Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Futibatinib
Antineoplastic Agents