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A Study of TAS-120 in Patients With Advanced Solid Tumors
Bu çalışma, standart tedavisi başarısız olmuş ileri solid (katı) tümörü olan hastalarda, özellikle FGF/FGFR gen değişikliği taşıyanlarda, TAS-120 (Futibatinib) ilacını inceliyor. Doğrulanmış ileri kanseri olan hastalar dahil edilmiştir. Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
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.
Exclusion Criteria:
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
4. A serious illness or medical condition(s)
5. Pregnant or breast-feeding female