Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Taiho Oncology, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Provide written informed consent
2. Age ≥ 18 years of age
3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer
4. The following specific criteria for each study portion
Phase 1 (Dose Escalation):
* Patients with any type of solid tumor
* Disease progression following standard therapies or intolerant to prior standard therapies
Phase 1 (Dose Expansion)
* Have at least one FGF/FGFR aberration
* Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
* Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or Response Assessment in Neuro-Oncology criteria (2010) for brain tumors.
* Patients with any of the following tumor types
* Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
* Patients with primary CNS tumors
* Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
* Patients with breast cancer or gastric cancer
* Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
* Patients with solid tumor types and other FGF/FGFR alterations not listed above
Phase 2
* Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
* Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
* Must have documentation of radiographic progression of disease
* No prior FGFR inhibitor
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function.
You may not be if
1. History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
3. History and/or current evidence of clinically significant retinal disorder
