A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS
Phase II study of TAS-120
Taiho Pharmaceutical Co., Ltd.
1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
+81-3-3293-2113
th-TAS120-info@taiho.co.jp
Taiho Pharmaceutical Co., Ltd.
1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
+81-3-3293-2113
toiawase@taiho.co.jp
completed
July. 20, 2020
155
Interventional
This is an open-label, multinational, 3-arm Phase 2 study
treatment purpose
2
1. Provide written informed consent
2. >=18 years of age
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Adequate organ function
5. Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
Cohort A
Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4 rearrangement. Patients with primary brain tumor or intrahepatic cholangiocarcinoma are not eligible
Measurable disease per RECIST 1.1
Had disease progression/recurrence after standard treatment for their advanced or metastatic cancer
Cohort B
Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or GEJ cancer harboring a FGFR2 amplification
Measurable disease per RECIST 1.1
Received at least 2 prior systemic regimens for advanced/metastatic disease
Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric or GEJ cancer
Cohort C
Confirmed myeloid/ lymphoid neoplasms with a FGFR1 rearrangement
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
1. A serious illness or medical condition
2. History and/or current evidence of any of the following disorders:
Non-tumor related alteration of the calcium-phosphorus homeostasis
Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung
Retinal or corneal disorder confirmed by retinal/corneal examination
3. Prior treatment with an FGFR inhibitor
4. Active central nervous system metastasis and/or carcinomatous meningitis
18age old over
No limit
Both
Cancer with specific FGFR aberrations
investigational material(s)
Generic name etc : TAS-120 : futibatinib
INN of investigational material : TAS-120 : futibatinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : A once-daily repeated dose, 20 mg/body/day
Oral
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
