Esophageal Cancer Clinical Trial
Futibatinib in Patients With Specific FGFR Aberrations
Summary
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.
Full 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.
Eligibility Criteria
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:
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)
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There are 58 Locations for this study
Gilbert Arizona, 85234, United States
Los Angeles California, 90404, United States
Washington District of Columbia, 20007, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Woodhaven Michigan, 48183, United States
Oklahoma City Oklahoma, 73120, United States
Philadelphia Pennsylvania, 53705, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Bruxelles , 1000, Belgium
Nice Alpes Maritimes, 06200, France
Strasbourg Bas Rhin, 67000, France
Dijon Côte-d'Or, 21079, France
Bordeaux Gironde, 33076, France
Paris Cedex 10 Paris, 75475, France
Lyon Rhone, 69008, France
Pierre Benite cedex Rhone, 69495, France
Villejuif Val De Marne, 94805, France
Freiburg Baden Wuerttemberg, 79106, Germany
Heidelberg Baden Wuerttemberg, 69120, Germany
Koeln Nordrhein Westfalen, 50924, Germany
Hong Kong , , Hong Kong
Jordon , 0000, Hong Kong
Meldola Forli - Cesena, 47014, Italy
Negrar Verona, 37024, Italy
Florence , 50134, Italy
Milano , 20141, Italy
Verona , 37124, Italy
Nagoya-shi Aichi-Ken, 464-8, Japan
Kashiwa-shi Chiba-Ken, 277-8, Japan
Matsuyama-shi Ehime-Ken, 791-0, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Suita-shi Osaka-Fu, 565-0, Japan
Chuo-ku Tokyo-To, 104-0, Japan
Seongnam Gyeonggi-do, 13620, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seul , 03080, Korea, Republic of
Seul , 03722, Korea, Republic of
Seul , 06351, Korea, Republic of
Amsterdam , 1066 , Netherlands
Rotterdam , 3015 , Netherlands
Lisboa , 1169-, Portugal
Lisboa , 4099-, Portugal
Porto , 4099-, Portugal
Singapore , 11907, Singapore
Barcelona , 08035, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Sevilla , 41009, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Solna , 171 6, Sweden
Uppsala , 75185, Sweden
Adana , 01130, Turkey
Istanbul , 34457, Turkey
Tekirdağ , 59100, Turkey
London Greater London, W1G 6, United Kingdom
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