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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02052778
Registration number
NCT02052778
Ethics application status
Date submitted
23/01/2014
Date registered
3/02/2014
Date last updated
20/03/2024
Titles & IDs
Public title
A Study of TAS-120 in Patients With Advanced Solid Tumors
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Scientific title
Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations
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Secondary ID [1]
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2013-004810-16
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Secondary ID [2]
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TPU-TAS-120-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cholangiocarcinoma
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Urothelial Cancer
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Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors
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Primary CNS Tumors
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Breast Cancer
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Gastric Cancer
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Condition category
Condition code
Cancer
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Futibatinib
Experimental: Phase 1: Dose Escalation: QOD Dosing: 8 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 16 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 24 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 36 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 56 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 80 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 120 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 160 mg - 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.
Experimental: Phase 1: Dose Escalation: QOD Dosing: 200 mg - 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.
Experimental: Phase 1: Dose Escalation: QD Dosing: 4 mg - 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.
Experimental: Phase 1: Dose Escalation: QD Dosing: 8 mg - 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.
Experimental: Phase 1: Dose Escalation: QD Dosing: 16 mg - 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.
Experimental: Phase 1: Dose Escalation: QD Dosing: 20 mg - 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.
Experimental: Phase 1: Dose Escalation: QD Dosing: 24 mg - 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.
Experimental: Phase 1: Dose Expansion Cohort 1 - 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.
Experimental: Phase 1: Dose Expansion: Cohort 2 - 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.
Experimental: Phase 1: Dose Expansion: Cohort 3 - 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.
Experimental: Phase 1: Dose Expansion: Cohort 4 - 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.
Experimental: Phase 1:Dose Expansion: Cohort 5 - 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.
Experimental: Phase 1: Dose Expansion: Cohort 6 - 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.
Experimental: Phase 1: Dose Expansion: Sub-cohort 1 - 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.
Experimental: Phase 1: Dose Expansion: Sub-cohort 2 - 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.
Experimental: Phase 2 - 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.
Treatment: Drugs: Futibatinib
oral once daily dosing, 21-day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)
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Assessment method [1]
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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.
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Timepoint [1]
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Cycle 1 (21-day cycle)
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Primary outcome [2]
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Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120
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Assessment method [2]
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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.
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Timepoint [2]
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Cycle 1 (21-day cycle)
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Primary outcome [3]
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Phase 1: Dose Expansion: Percentage of Participants With Objective Response
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Assessment method [3]
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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.
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Timepoint [3]
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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
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Primary outcome [4]
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Phase 2: Percentage of Participants With Objective Response
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 37.5 months (through cut-off date 29-May-2021)
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Secondary outcome [1]
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Phase 1: Dose Expansion: Duration of Response (DOR)
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Assessment method [1]
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A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. For Cohorts 1 to 6: DOR was based on IRC and for Group 3, 4, 5, 6 and for pooled Sub-cohort: DOR was based on investigator review.
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Timepoint [1]
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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
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Secondary outcome [2]
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Phase 2: Duration of Response (DOR)
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Assessment method [2]
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A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. Kaplan-Meier method was used for the analysis.
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Timepoint [2]
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Up to approximately 37.5 months (through cut-off date 29-May-2021)
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Secondary outcome [3]
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Phase 1: Dose Expansion: Disease Control Rate (DCR)
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Assessment method [3]
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A DCR was defined as the proportion of participants with objective evidence of CR, PR, or stable disease (SD), except that there was no requirement for a confirmation of an SD, if it is maintained for at least 6 weeks post treatment initiation. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes might had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the Baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as a reference the smallest sum diameters while on study. For Cohorts 1 to 6: DCR was based on IRC and for pooled Sub-cohort: DCR was based on investigator review.
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Timepoint [3]
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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
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Secondary outcome [4]
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Phase 2: Disease Control Rate (DCR)
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Assessment method [4]
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A DCR was defined as the proportion of participants with objective evidence of CR, PR, or SD, except that there was no requirement for a confirmation of an SD response, if it is maintained for at least 6 weeks post treatment initiation. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes might had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the Baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as a reference the smallest sum diameters while on study. DCR was based on IRC.
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Timepoint [4]
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Up to approximately 37.5 months (through cut-off date 29-May-2021)
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Secondary outcome [5]
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Phase 1: Dose Expansion: Progression-free Survival (PFS)
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Assessment method [5]
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A PFS was defined as the time (in months) from the day of the first dose to the date of first documented disease progression or death (due to any cause), whichever occurred first. Participants who died without a reported disease progression were considered to have progressed on the date of their death, participants who did not progress or die were censored on the date of their last tumor assessment, participants who had no on-study assessments and did not die were censored on the first dosing date, and participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. PFS assessment per protocol was by IRC assessment for Cohorts 1 to 6 and for pooled Sub-cohort: PFS was based on investigator review.
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Timepoint [5]
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up to approximately 27.5 months (through cut-off date 30-Jun-2019)
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Secondary outcome [6]
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Phase 2: Progression-free Survival (PFS)
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Assessment method [6]
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A PFS was defined as the time (in months) from the day of the first dose to the date of first objectively documented disease progression or death (any cause), whichever occurred first. Participants who had died without a reported disease progression were considered to have progressed on the date of their death, participants who did not progress or die were censored on the date of their last tumor assessment, participants who had no on-study assessments and did not die were censored on the first dosing date, and participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. PFS was analyzed as using Kaplan-Meier estimate.
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Timepoint [6]
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Up to approximately 37.5 months (through cut-off date 29-May-2021)
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Secondary outcome [7]
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Phase 1: Dose Expansion: Overall Survival (OS)
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Assessment method [7]
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An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
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Timepoint [7]
0
0
up to approximately 27.5 months (through cut-off date 30-Jun-2019)
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Secondary outcome [8]
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Phase 2: Overall Survival (OS)
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Assessment method [8]
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An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
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Timepoint [8]
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Up to approximately 37.5 months (through cut-off date 29-May-2021)
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Secondary outcome [9]
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Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits
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Assessment method [9]
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EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
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Timepoint [9]
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Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [10]
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Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits
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Assessment method [10]
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EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
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Timepoint [10]
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0
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [11]
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Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits
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Assessment method [11]
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EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
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Timepoint [11]
0
0
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [12]
0
0
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits
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Assessment method [12]
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EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
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Timepoint [12]
0
0
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [13]
0
0
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Anxiety/Depression Scores at Specified Visits
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Assessment method [13]
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0
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
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Timepoint [13]
0
0
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [14]
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Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits
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Assessment method [14]
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EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A vertical VAS allows the participants to indicate their health state that day, and ranged from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.
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Timepoint [14]
0
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Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [15]
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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
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Assessment method [15]
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EORTC QLQ-C30 is a cancer-specific instrument that contains 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale & are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as ([{Q29+Q30}/2]-1)/6*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant.
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Timepoint [15]
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Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
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Secondary outcome [16]
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0
Phase 1: Dose Expansion: Number of Participants With Any Adverse Events (AEs) and Any Serious AEs (SAEs)
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Assessment method [16]
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An AE was defined as any untoward medical condition that occurred in a participant from the time the informed consent form (ICF) was signed and does not necessarily had a causal relationship with the use of the product. An SAE was an AE that falls into one or more of the following categories: a. resulted in death, b. was life threatening, c. required inpatient hospitalization or prolongation of existing hospitalization, d. resulted in persistent or significant disability or incapacity, e. was a congenital anomaly/birth defect, f. other important medical event.
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Timepoint [16]
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From the first dose up to approximately 50.5 months (through cut-off date 29-May-2021)
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Secondary outcome [17]
0
0
Phase 2: Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
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Assessment method [17]
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An AE was defined as any untoward medical condition that occurs in a participant from the time the informed consent form (ICF) was signed and does not necessarily had a causal relationship with the use of the product. An SAE was an AE that falls into one or more of the following categories: a. resulted in death, b. was life threatening, c. required inpatient hospitalization or prolongation of existing hospitalization, d. resulted in persistent or significant disability or incapacity, e. was a congenital anomaly/birth defect, f. other important medical event.
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Timepoint [17]
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From the first dose up to approximately 37.5 months (through cut-off date 29-May-2021)
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Eligibility
Key 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
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)
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/05/2021
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Sample size
Target
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Accrual to date
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Final
407
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Georgia
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Illinois
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Kansas
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Massachusetts
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Michigan
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Minnesota
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New Mexico
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New York
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Pennsylvania
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South Carolina
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Canada
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Toronto
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France
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Cedex
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France
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Bordeaux
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France
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Bron
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France
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Paris
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France
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Rennes cedex
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France
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Villejuif
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Germany
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Essen
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Hong Kong
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Sha Tin
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Italy
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Milano
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Italy
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Padova
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Japan
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Hokkaido
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Netherlands
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Jenna
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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London
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United Kingdom
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State/province [41]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Taiho Oncology, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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. 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02052778
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02052778
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