Futibatinib in Patients With Specific FGFR Aberrations
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| ClinicalTrials.gov Identifier: NCT04189445 |
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Recruitment Status :
Active, not recruiting
First Posted : December 6, 2019
Last Update Posted : March 24, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced or Metastatic Solid Tumor Advanced or Metastatic Gastric or Gastroesophageal Cancer Myeloid or Lymphoid Neoplasms (MLN) | Drug: Futibatinib | Phase 2 |
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:
- Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA;
- Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification;
- Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 115 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations |
| Actual Study Start Date : | August 24, 2020 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | October 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Futibatinib (Cohort A)
Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements
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Drug: Futibatinib
Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
Other Name: TAS-120 |
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Experimental: Futibatinib (Cohort B)
Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification
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Drug: Futibatinib
Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
Other Name: TAS-120 |
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Experimental: Futibatinib (Cohort C)
Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement
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Drug: Futibatinib
Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
Other Name: TAS-120 |
- Objective response rate (ORR) in Cohorts A and B [ Time Frame: Approximately 6 months ]ORR, defined as the proportion of patients 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 independent central review of radiological images.
- Complete response (CR) rate in Cohort C [ Time Frame: Approximately 6 months ]CR rate, defined as the proportion of patients who achieved a CR (per response criteria for MLN) based on investigators' assessment of imaging, peripheral blood, and bone marrow.
- ORR based on investigator assessment ORR in Cohorts A and B [ Time Frame: Approximately 6 months ]ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment.
- Duration of Response (DOR) in Cohorts A, B and C [ Time Frame: Approximately 6 months ]DOR, defined as the time from the first documentation of response (CR or PR in Cohorts A and B; CR, PR, or CRi in Cohort C) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
- Progression- free survival (PFS) in Cohorts A, B and C [ Time Frame: Approximately 6 months ]PFS, defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression, whichever occurs first.
- Overall Survival (OS) in Cohorts A, B and C [ Time Frame: Approximately 12 months ]OS, defined as the time from the date of first dose to the death date.
- Disease control rate (DCR) in Cohort A and B [ Time Frame: Approximately 6 months ]DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR) (per RECIST 1.1).
- CR+CRi rate in Cohort C [ Time Frame: Approximately 6 months ]CR+CRi rate, defined as the proportion of patients who achieved a CR or CRi
- Duration of CR in Cohort C [ Time Frame: Approximately 6 months ]Duration of CR, 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.
- Duration of CR+CRi in Cohort C [ Time Frame: Approximately 6 months ]Duration of CR+CRi, 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.
- Complete cytogenetic response (CCyR) rate in Cohort C. [ Time Frame: Approximately 6 months ]CCyR rate, defined as the proportion of patients who achieved a CCyR
- Partial cytogenetic response (PCyR) rate in Cohort C [ Time Frame: Approximately 6 months ]PCyR rate, defined as the proportion of patients who achieved a PCyR
- Relapse-free survival (RFS) in Cohort C [ Time Frame: Approximately 6 months ]RFS, 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
- Event-free survival (EFS) in Cohort C [ Time Frame: Approximately 6 months ]EFS, defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or patient death due to any cause, whichever occurs first
- To assess the safety and tolerability in Cohorts A, B and C [ Time Frame: Approximately 6 months ]Safety based on reported AEs will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse events (NCI-CTCAE), Version 5.0.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
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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:
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History and/or current evidence of any of the following disorders:
- Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
- Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator
- Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator.
- Prior treatment with an FGFR inhibitor
- Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189445
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| Responsible Party: | Taiho Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT04189445 |
| Other Study ID Numbers: |
TAS-120-202 2019-004084-49 ( EudraCT Number ) |
| First Posted: | December 6, 2019 Key Record Dates |
| Last Update Posted: | March 24, 2023 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Futibatinib Gastric cancer Gastro-esophageal junction cancer Solid tumor Myeloid neoplasm |
Lymphoid neoplasm FGFR Amplification Rearrangement TAS-120 |
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Neoplasms Futibatinib Antineoplastic Agents |