Trial · NCT02052778
A Study of TAS-120 in Patients With Advanced Solid Tumors
NCT02052778, Phase 1, Phase 2, Completed, Taiho Oncology, Inc.; results first posted 2024-03-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of TAS-120 in Patients With Advanced Solid Tumors. Trials, record NCT02052778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAS-120 in Patients With Advanced Solid Tumors
- NCT number
- NCT02052778
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 407 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Cholangiocarcinoma, Urothelial Cancer, Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors, Primary CNS Tumors, Breast Cancer, Gastric Cancer
- Interventions
- Futibatinib
- First posted
- 2014-02-03
- Last updated
- 2025-03-27
- Other registries' IDs
- eudract:2013-004810-16
- Results first posted
- 2024-03-20
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD) | Cycle 1 (21-day cycle) | 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. |
| Primary | Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120 | Cycle 1 (21-day cycle) | 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. |
| Primary | Phase 1: Dose Expansion: Percentage of Participants With Objective Response | 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 | 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. |
| Primary | Phase 2: Percentage of Participants With Objective Response | Up to approximately 37.5 months (through cut-off date 29-May-2021) | 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. |
| Secondary | Phase 1: Dose Expansion: Duration of Response (DOR) | Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts | 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. |
| Secondary | Phase 2: Duration of Response (DOR) | Up to approximately 37.5 months (through cut-off date 29-May-2021) | 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. |
| Secondary | Phase 1: Dose Expansion: Disease Control Rate (DCR) | Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohort | 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. |
| Secondary | Phase 2: Disease Control Rate (DCR) | Up to approximately 37.5 months (through cut-off date 29-May-2021) | 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. |
| Secondary | Phase 1: Dose Expansion: Progression-free Survival (PFS) | up to approximately 27.5 months (through cut-off date 30-Jun-2019) | 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. |
| Secondary | Phase 2: Progression-free Survival (PFS) | Up to approximately 37.5 months (through cut-off date 29-May-2021) | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD) | Cycle 1 (21-day cycle) | Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered. | Milligrams | NUMBER |
| PRIMARY | Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120 | Cycle 1 (21-day cycle) | Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered. | Milligrams | NUMBER |
| PRIMARY | Phase 1: Dose Expansion: Percentage of Participants With Objective Response | 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 | Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1and 2. | Percentage of participants | NUMBER |
| PRIMARY | Phase 2: Percentage of Participants With Objective Response | Up to approximately 37.5 months (through cut-off date 29-May-2021) | Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1: Dose Expansion: Duration of Response (DOR) | Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts | Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2. | months | MEDIAN |
| SECONDARY | Phase 2: Duration of Response (DOR) | Up to approximately 37.5 months (through cut-off date 29-May-2021) | Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | months | MEDIAN |
| SECONDARY | Phase 1: Dose Expansion: Disease Control Rate (DCR) | Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohort | Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2. | Percentage of participants | NUMBER |
| SECONDARY | Phase 2: Disease Control Rate (DCR) | Up to approximately 37.5 months (through cut-off date 29-May-2021) | Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1: Dose Expansion: Progression-free Survival (PFS) | up to approximately 27.5 months (through cut-off date 30-Jun-2019) | Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2. | months | MEDIAN |
| SECONDARY | Phase 2: Progression-free Survival (PFS) | Up to approximately 37.5 months (through cut-off date 29-May-2021) | Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120. | months | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group330
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD) | Phase 1: Dose Escalation: QOD Dosing | NA | Milligrams | ||
| Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD) | Phase 1: Dose Escalation: QD Dosing | 20 | Milligrams | ||
| Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120 | Phase 1: Dose Escalation: QOD Dosing | NA | Milligrams | ||
| Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120 | Phase 1: Dose Escalation: QD Dosing | 20 | Milligrams | ||
| Phase 1: Dose Expansion: Percentage of Participants With Objective Response | Phase 1: Dose Expansion Cohort 1 | 15.8 | 95% Confidence Interval 7.5 to 27.9 | Percentage of participants | |
| Phase 1: Dose Expansion: Percentage of Participants With Objective Response | Phase 1: Dose Expansion: Cohort 2 | 8.8 | 95% Confidence Interval 1.9 to 23.7 | Percentage of participants | |
| Phase 1: Dose Expansion: Percentage of Participants With Objective Response | Phase 1: Dose Expansion: Cohort 3 | 13.3 | 95% Confidence Interval 1.7 to 40.5 | Percentage of participants | |
| Phase 1: Dose Expansion: Percentage of Participants With Objective Response | Phase 1: Dose Expansion: Cohort 4 | 0 | 95% Confidence Interval 0.0 to 24.7 | Percentage of participants | |
| Phase 1: Dose Expansion: Percentage of Participants With Objective Response | Phase 1: Dose Expansion: Cohort 5 | 12.5 | 95% Confidence Interval 2.7 to 32.4 | Percentage of participants | |
| Phase 1: Dose Expansion: Percentage of Participants With Objective Response | Phase 1: Dose Expansion: Cohort 6 | 0 | 95% Confidence Interval 0.0 to 12.8 | Percentage of participants |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 results by groupParticipant flow253
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 8 mg | 6 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 16 mg | 3 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 24 mg | 3 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 36 mg | 3 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 56 mg | 3 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 80 mg | 5 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 120 mg | 4 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 160 mg | 8 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QOD Dosing: 200 mg | 7 | |
| Dose Escalation(Approximately 60 Months) | STARTED | Phase 1: Dose Escalation: QD Dosing: 4 mg | 4 |
1 to 10 of 253Source ClinicalTrials.gov
See all 253 participant flowAdverse events11,339
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 | Phase 1: Dose Escalation: QOD Dosing: 8 mg | 2 | 6 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 16 mg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 24 mg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 36 mg | 1 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 56 mg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 80 mg | 1 | 5 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 120 mg | 2 | 4 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 160 mg | 4 | 8 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QOD Dosing: 200 mg | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation: QD Dosing: 4 mg | 1 | 4 | 1 |
1 to 10 of 11,339Source ClinicalTrials.gov
See all 11,339 adverse eventsAdverse event totals69
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 8 mg | 0 | 6 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 16 mg | 0 | 3 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 24 mg | 0 | 3 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 36 mg | 0 | 3 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 56 mg | 0 | 3 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 80 mg | 0 | 5 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 120 mg | 1 | 4 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 160 mg | 0 | 8 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QOD Dosing: 200 mg | 2 | 7 |
| Total, all-cause mortality | Phase 1: Dose Escalation: QD Dosing: 4 mg | 0 | 4 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02052778
GET https://conductscience.org/api/trials/v1/NCT02052778/registered?page=2