Description:
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.
Title
- Brief Title: Futibatinib in Patients With Specific FGFR Aberrations
- Official Title: A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS
Clinical Trial IDs
- ORG STUDY ID:
TAS-120-202
- SECONDARY ID:
2019-004084-49
- NCT ID:
NCT04189445
Conditions
- Advanced or Metastatic Solid Tumor
- Advanced or Metastatic Gastric or Gastroesophageal Cancer
- Myeloid or Lymphoid Neoplasms (MLN)
Interventions
Drug | Synonyms | Arms |
---|
Futibatinib | TAS-120 | Futibatinib (Cohort A) |
Purpose
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.
Detailed Description
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
Trial Arms
Name | Type | Description | Interventions |
---|
Futibatinib (Cohort A) | Experimental | Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements | |
Futibatinib (Cohort B) | Experimental | Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification | |
Futibatinib (Cohort C) | Experimental | Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement | |
Eligibility Criteria
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
2. 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:
1. History and/or current evidence of any of the following disorders:
1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is
considered clinically significant in the opinion of the Investigator
2. 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
3. Retinal or corneal disorder confirmed by retinal/corneal examination and
considered clinically significant in the opinion of the Investigator.
2. Prior treatment with an FGFR inhibitor
3. Brain metastases that are untreated or clinically or radiologically unstable (that is,
have been stable for <1 month)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) in Cohorts A and B |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) in Cohorts A, B, and C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | ORR, defined as the proportion of patients experiencing a best overall response of complete response (CR) or partial response (PR) in Cohorts A and B; CR, PR, or complete response with incomplete hematological recovery (CRi) in Cohort C |
Measure: | Duration of Response (DOR) in Cohorts A, B and C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Progression- free survival (PFS) in Cohorts A, B and C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Overall Survival (OS) in Cohorts A, B and C |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | OS, defined as the time from the date of first dose to the death date. |
Measure: | Disease control rate (DCR) in Cohort A and B |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR). |
Measure: | CR+CRi rate in Cohort C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | CR+CRi rate, defined as the proportion of patients who achieved a CR or CRi |
Measure: | Duration of CR in Cohort C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Duration of CR+CRi in Cohort C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Complete cytogenetic response (CCyR) rate in Cohort C. |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | CCyR rate, defined as the proportion of patients who achieved a CCyR |
Measure: | Partial cytogenetic response (PCyR) rate in Cohort C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | PCyR rate, defined as the proportion of patients who achieved a PCyR |
Measure: | Relapse-free survival (RFS) in Cohort C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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 |
Measure: | Event-free survival (EFS) in Cohort C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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 |
Measure: | To assess the safety and tolerability in Cohorts A, B and C |
Time Frame: | Approximately 6 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Taiho Oncology, Inc. |
Trial Keywords
- Futibatinib
- Gastric cancer
- Gastro-esophageal junction cancer
- Solid tumor
- Myeloid neoplasm
- Lymphoid neoplasm
- FGFR
- Amplification
- Rearrangement
- TAS-120
Last Updated
July 15, 2021