Cancer with specific FGFR aberrations
Conditions
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics pharmacogenomics Safety, Efficacy, Pharmacokinetic analysis, Pharmacodynamic analysis, Pharmacogenomics analysis | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed