Trial · NCT04189445
Futibatinib in Patients With Specific FGFR Aberrations
NCT04189445, Phase 2, Terminated, Taiho Oncology, Inc.; results first posted 2025-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Futibatinib in Patients With Specific FGFR Aberrations. Trials, record NCT04189445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04189445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Futibatinib in Patients With Specific FGFR Aberrations
- NCT number
- NCT04189445
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 115 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN)
- Interventions
- Futibatinib
- First posted
- 2019-12-06
- Last updated
- 2025-10-08
- Other registries' IDs
- eudract:2019-004084-49
- Results first posted
- 2025-10-08
- Limitations and caveats
- The Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Primary | Complete Response (CR) Rate in Cohort C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | ORR Based on Investigator Assessment in Cohorts A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | Duration of Response (DOR) Based on IRC in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | DOR Based on Investigator Assessment in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | PFS Based on Investigator Review in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | Overall Survival (OS) in Cohorts A, B and C | Up to 31 months | 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. |
| Secondary | Disease Control Rate (DCR) Based on IRC in Cohort A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
| Secondary | DCR Based on Investigator Review in Cohort A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | All treated population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Complete Response (CR) Rate in Cohort C | At the end of every 2 cycles until disease progression (Up to 31 months) | No participants were enrolled in Cohort C, hence no data was collected. | ||
| SECONDARY | ORR Based on Investigator Assessment in Cohorts A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | All treated population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Based on IRC in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. | months | MEDIAN |
| SECONDARY | DOR Based on Investigator Assessment in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. | months | MEDIAN |
| SECONDARY | Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. | months | MEDIAN |
| SECONDARY | PFS Based on Investigator Review in Cohorts A, B and C | At the end of every 2 cycles until disease progression (Up to 31 months) | 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. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Cohorts A, B and C | Up to 31 months | 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. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on IRC in Cohort A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | All treated population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | DCR Based on Investigator Review in Cohort A and B | At the end of every 2 cycles until disease progression (Up to 31 months) | All treated population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B | Futibatinib (Cohort A) | 6.9 | 95% Confidence Interval 2.6 to 14.4 | percentage of participants | |
| Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B | Futibatinib (Cohort B) | 17.9 | 95% Confidence Interval 6.1 to 36.9 | percentage of participants | |
| ORR Based on Investigator Assessment in Cohorts A and B | Futibatinib (Cohort A) | 9.2 | 95% Confidence Interval 4.1 to 17.3 | percentage of participants | |
| ORR Based on Investigator Assessment in Cohorts A and B | Futibatinib (Cohort B) | 10.7 | 95% Confidence Interval 2.3 to 28.2 | percentage of participants | |
| Duration of Response (DOR) Based on IRC in Cohorts A, B and C | Futibatinib (Cohort A) | 5.6 | 95% Confidence Interval 3.5 to NA | months | |
| Duration of Response (DOR) Based on IRC in Cohorts A, B and C | Futibatinib (Cohort B) | 3.9 | 95% Confidence Interval 2.1 to NA | months | |
| DOR Based on Investigator Assessment in Cohorts A, B and C | Futibatinib (Cohort A) | 5.6 | 95% Confidence Interval 3.0 to NA | months | |
| DOR Based on Investigator Assessment in Cohorts A, B and C | Futibatinib (Cohort B) | 5.6 | 95% Confidence Interval 2.0 to NA | months | |
| Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C | Futibatinib (Cohort A) | 1.9 | 95% Confidence Interval 1.8 to 3.5 | months | |
| Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C | Futibatinib (Cohort B) | 2.9 | 95% Confidence Interval 1.8 to 3.7 | months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Futibatinib (Cohort A) | 87 | |
| Overall Study | STARTED | Futibatinib (Cohort B) | 28 | |
| Overall Study | STARTED | Futibatinib (Cohort C) | 0 | |
| Overall Study | COMPLETED | Futibatinib (Cohort A) | 0 | |
| Overall Study | COMPLETED | Futibatinib (Cohort B) | 0 | |
| Overall Study | COMPLETED | Futibatinib (Cohort C) | 0 | |
| Overall Study | NOT COMPLETED | Futibatinib (Cohort A) | 87 | |
| Overall Study | NOT COMPLETED | Futibatinib (Cohort B) | 28 | |
| Overall Study | NOT COMPLETED | Futibatinib (Cohort C) | 0 |
Source ClinicalTrials.gov
Adverse events498
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Futibatinib (Cohort A) | 16 | 87 | |
| other | Anaemia | Blood and lymphatic system disorders | Futibatinib (Cohort B) | 3 | 28 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Futibatinib (Cohort A) | 1 | 87 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Futibatinib (Cohort B) | 0 | 28 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Futibatinib (Cohort A) | 1 | 87 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Futibatinib (Cohort B) | 0 | 28 | |
| other | Sinus bradycardia | Cardiac disorders | Futibatinib (Cohort A) | 2 | 87 | |
| other | Sinus bradycardia | Cardiac disorders | Futibatinib (Cohort B) | 0 | 28 | |
| other | Cardiac disorder | Cardiac disorders | Futibatinib (Cohort A) | 1 | 87 | |
| other | Cardiac disorder | Cardiac disorders | Futibatinib (Cohort B) | 0 | 28 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Futibatinib (Cohort A) | 54 | 87 |
| Total, all-cause mortality | Futibatinib (Cohort B) | 24 | 28 |
| Total, other adverse events | Futibatinib (Cohort A) | 86 | 87 |
| Total, other adverse events | Futibatinib (Cohort B) | 27 | 28 |
| Total, serious adverse events | Futibatinib (Cohort A) | 23 | 87 |
| Total, serious adverse events | Futibatinib (Cohort B) | 6 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Futibatinib (Cohort A) vs Futibatinib (Cohort B): deaths from any cause | Trial comparisons |
| Futibatinib (Cohort A) vs Futibatinib (Cohort B): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04189445
GET https://conductscience.org/api/trials/v1/NCT04189445/events?page=2