Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004084-49 | EudraCT Number |
Not provided
Not provided
Not provided
Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.
Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.
Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle.
The study will enroll approximately:
Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first).
Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.
Additional cohorts may be added in the future in case of new emerging efficacy data.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Futibatinib (Cohort A) | Experimental | Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days. |
|
| Futibatinib (Cohort B) | Experimental | Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days. |
|
| Futibatinib (Cohort C) | Experimental | Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Futibatinib | Drug | Futibatinib tablets were dosed orally every day on a continuous 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B | ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| Complete Response (CR) Rate in Cohort C | CR rate was defined as the percentage of participants who achieved a CR (per response criteria for myeloid or lymphoid neoplasm) based on investigator assessment of imaging, peripheral blood, and bone marrow. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR Based on Investigator Assessment in Cohorts A and B | ORR was defined as the percentage of participants experiencing a best overall response of PR or CR (per RECIST 1.1), based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. |
Not provided
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
a. Cohort A
i. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4
ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
iii. Had disease progression/recurrence after standard treatment for their cancer
b. Cohort B
i. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification.
ii. Measurable disease per RECIST 1.1
iii. Received at least 2 prior systemic regimens for advanced/metastatic disease
iv. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer
c. Cohort C
i. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement
ii. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies
Exclusion Criteria:
History and/or current evidence of any of the following disorders:
Prior treatment with an FGFR inhibitor
Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234-2165 | United States | ||
| UCLA Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 115 participants were enrolled in Cohort A and Cohort B to receive futibatinib; no participants were enrolled in Cohort C.
Participants took part in the study from 05 August 2020 to 11 November 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Futibatinib (Cohort A) | Participants with advanced or metastatic solid tumors harboring fibroblast growth factor receptor (FGFR)1-4 rearrangements received futibatinib 20 milligrams (mg), oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days. |
| FG001 | Futibatinib (Cohort B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2021 | Sep 19, 2025 |
Not provided
The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts
Not provided
Not provided
Not provided
Not provided
|
| At the end of every 2 cycles until disease progression (Up to 31 months) |
| Duration of Response (DOR) Based on IRC in Cohorts A, B and C | DOR was defined as the time from the first documentation of response (CR or PR in based on IRC) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. DOR was estimated using the Kaplan-Meier method. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| DOR Based on Investigator Assessment in Cohorts A, B and C | DOR was defined as the time from the first documentation of response (CR or PR in based on Investigator Assessment) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. DOR was estimated using the Kaplan-Meier method. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C | PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| PFS Based on Investigator Review in Cohorts A, B and C | PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on Investigator Review), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| Overall Survival (OS) in Cohorts A, B and C | OS was defined as the time from the date of first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure. | Up to 31 months |
| Disease Control Rate (DCR) Based on IRC in Cohort A and B | DCR was defined as the percentage of participants experiencing a best overall response of stable disease (SD), PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| DCR Based on Investigator Review in Cohort A and B | DCR was defined as the percentage of participants experiencing a best overall response of SD, PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (Up to 31 months) |
| CR+ Complete Response With Incomplete Hematological Recovery (CRi) Rate in Cohort C | CR+CRi rate was defined as the percentage of participants who achieved a CR or CRi. | Up to 31 months |
| Duration of CR in Cohort C | Duration of CR was defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first. | Up to 31 months |
| Duration of CR+CRi in Cohort C | Duration of CR+CRi was defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first. | Up to 31 months |
| Complete Cytogenetic Response (CCyR) Rate in Cohort C | CCyR rate was defined as the percentage of participants who achieved a CCyR. | Up to 31 months |
| Partial Cytogenetic Response (PCyR) Rate in Cohort C | PCyR rate was defined as the percentage of participants who achieved a PCyR. | Up to 31 months |
| Relapse-free Survival (RFS) in Cohort C | RFS was defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first. | Up to 31 months |
| Event-free Survival (EFS) in Cohort C | EFS was defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or participant death due to any cause, whichever occurs first. | Up to 31 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Cohort A, B and C | An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. A treatment-emergent AE (TEAE) is defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug, and does not necessarily have a causal relationship to the use of the study drug. | From the first dose of study drug up to 30 days after the last dose (Up to 31 months) |
| Los Angeles |
| California |
| 90404 |
| United States |
| Georgetown University - Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215-5400 | United States |
| Henry Ford Hospital | Woodhaven | Michigan | 48183 | United States |
| Mercy Clinic Oncology and Hematology - Coletta | Oklahoma City | Oklahoma | 73120 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 53705 | United States |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | United States |
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Centre Antoine Lacassagne | Nice | Alpes Maritimes | 06200 | France |
| Centre Paul Strauss | Strasbourg | Bas Rhin | 67000 | France |
| Centre Georges François Leclerc | Dijon | Côte-d'Or | 21079 | France |
| Institut Bergonié | Bordeaux | Gironde | 33076 | France |
| Hôpital Saint-Louis | Paris | Paris | 75475 | France |
| Centre Léon Bérard | Lyon | Rhone | 69008 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Rhone | 69495 | France |
| Institut Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50924 | Germany |
| The University of Hong Kong | Hong Kong | Hong Kong |
| Hong Kong United Oncology Centre | Jordon | 0000 | Hong Kong |
| Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori | Meldola | Forli - Cesena | 47014 | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | Verona | 37024 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| IEO Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento) | Verona | 37124 | Italy |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| NHO Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Osaka University Hospital | Suita-shi | Osaka | 565-0871 | Japan |
| National Cancer Center Hospital | Chūōku | Tokyo-To | 104-0045 | Japan |
| Antoni van Leeuwenhoek | Amsterdam | 1066 CX | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 AA | Netherlands |
| Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos | Lisbon | 1169-050 | Portugal |
| Fundação Champalimaud | Lisbon | 4099-001 | Portugal |
| Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| National University Cancer Institute | Singapore | 119074 | Singapore |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario HM Madrid Sanchinarro | Madrid | 28050 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Instituto Valenciano de Oncologia IVO | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Karolinska universitetssjukhuset - Solna | Solna | 171 64 | Sweden |
| Akademiska Sjukhuset | Uppsala | 75185 | Sweden |
| Acibadem Adana Hospital | Adana | 01130 | Turkey (Türkiye) |
| Acibadem Maslak Hospital | Istanbul | 34457 | Turkey (Türkiye) |
| Namik Kemal University | Tekirdağ | 59100 | Turkey (Türkiye) |
| Sarah Cannon Research Institute UK | London | Greater London | W1G 6AD | United Kingdom |
Participants with advanced or metastatic solid gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days. |
| FG002 | Futibatinib (Cohort C) | Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated population included all participants who received at least 1 dose of study drug. No participant was enrolled in Cohort C, hence no data was collected.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Futibatinib (Cohort A) | Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days. |
| BG001 | Futibatinib (Cohort B) | Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B | ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | All treated population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (Up to 31 months) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Complete Response (CR) Rate in Cohort C | CR rate was defined as the percentage of participants who achieved a CR (per response criteria for myeloid or lymphoid neoplasm) based on investigator assessment of imaging, peripheral blood, and bone marrow. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | At the end of every 2 cycles until disease progression (Up to 31 months) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | ORR Based on Investigator Assessment in Cohorts A and B | ORR was defined as the percentage of participants experiencing a best overall response of PR or CR (per RECIST 1.1), based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | All treated population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Based on IRC in Cohorts A, B and C | DOR was defined as the time from the first documentation of response (CR or PR in based on IRC) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. DOR was estimated using the Kaplan-Meier method. | All responders population included all participants who received at least 1 dose of study drug and had a response. No participants were enrolled in Cohort C, hence no data was collected. Overall number of participants analyzed is the number of participants with events. | Posted | Median | 95% Confidence Interval | months | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | DOR Based on Investigator Assessment in Cohorts A, B and C | DOR was defined as the time from the first documentation of response (CR or PR in based on Investigator Assessment) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. DOR was estimated using the Kaplan-Meier method. | All responders population included all participants who received at least 1 dose of study drug and had a response. No participants were enrolled in Cohort C, hence no data was collected. Overall number of participants analyzed is the number of participants with events. | Posted | Median | 95% Confidence Interval | months | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C | PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. | All treated population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with reported disease progression or death. No participants were enrolled in Cohort C, hence no data was collected. | Posted | Median | 95% Confidence Interval | months | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | PFS Based on Investigator Review in Cohorts A, B and C | PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on Investigator Review), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. | All treated population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with reported disease progression or death. No participants were enrolled in Cohort C, hence no data was collected. | Posted | Median | 95% Confidence Interval | months | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Cohorts A, B and C | OS was defined as the time from the date of first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure. | All treated population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with reported death. No participants were enrolled in Cohort C, hence no data was collected. | Posted | Median | 95% Confidence Interval | months | Up to 31 months |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Based on IRC in Cohort A and B | DCR was defined as the percentage of participants experiencing a best overall response of stable disease (SD), PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. Percentages were rounded off to the nearest single decimal place. | All treated population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | DCR Based on Investigator Review in Cohort A and B | DCR was defined as the percentage of participants experiencing a best overall response of SD, PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have 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. Percentages were rounded off to the nearest single decimal place. | All treated population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (Up to 31 months) |
| ||||||||||||||||||||||||||||||
| Secondary | CR+ Complete Response With Incomplete Hematological Recovery (CRi) Rate in Cohort C | CR+CRi rate was defined as the percentage of participants who achieved a CR or CRi. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of CR in Cohort C | Duration of CR was defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of CR+CRi in Cohort C | Duration of CR+CRi was defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Complete Cytogenetic Response (CCyR) Rate in Cohort C | CCyR rate was defined as the percentage of participants who achieved a CCyR. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Partial Cytogenetic Response (PCyR) Rate in Cohort C | PCyR rate was defined as the percentage of participants who achieved a PCyR. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Relapse-free Survival (RFS) in Cohort C | RFS was defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) in Cohort C | EFS was defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or participant death due to any cause, whichever occurs first. | No participants were enrolled in Cohort C, hence no data was collected. | Posted | Up to 31 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Cohort A, B and C | An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. A treatment-emergent AE (TEAE) is defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug, and does not necessarily have a causal relationship to the use of the study drug. | All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected. | Posted | Count of Participants | Participants | From the first dose of study drug up to 30 days after the last dose (Up to 31 months) |
|
From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
All treated population included all participants who received at least 1 dose of study drug. No participants were enrolled in Cohort C, hence no data was collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Futibatinib (Cohort A) | Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days. | 54 | 87 | 23 | 87 | 86 | 87 |
| EG001 | Futibatinib (Cohort B) | Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days. | 24 | 28 | 6 | 28 | 27 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid ptosis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Congenital dyskeratosis | Congenital, familial and genetic disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Retinal disorder | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Serous retinal detachment | Eye disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Effusion | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dermatophytosis of nail | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Neurological procedural complication | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood albumin abnormal | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Heart rate abnormal | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Myoglobin blood increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Palmoplantar keratoderma | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
|
The Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Oncology, Inc | Taiho Oncology, Inc | 609-250-7336 | clinicaltrialinfo@taihooncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2020 | Sep 19, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713257 | futibatinib |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Unknown |
|
| Not Hispanic or Latino |
|
| Unknown |
|
|
|
| OG002 | Futibatinib (Cohort C) | Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
|
|
| OG002 | Futibatinib (Cohort C) | Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
|
|
| Futibatinib (Cohort C) |
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
|
|
| Futibatinib (Cohort C) |
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
|
|
|
|
|
|
|
|
| Futibatinib (Cohort C) |
Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
|
|