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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Excerpt:
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study

Excerpt:
...all three patients with FGFR2-altered (fusion [n = 2] or mutation [n = 1]) cholangiocarcinoma with pre- and post-treatment target lesion assessments had reduced tumor burden (Fig 3)....BGJ398 demonstrated antitumor activity in FGFR1-amplified sqNSCLC, FGFR3-mutant bladder/urothelial cancer, and FGFR2-gene fusion/mutant cholangiocarcinoma, strongly supporting further biologic and clinical investigation.
DOI:
https://dx.doi.org/10.1200%2FJCO.2016.67.2048
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Updated results from a phase II study of infigratinib (BGJ398), a selective pan-FGFR kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions

Excerpt:
71 pts (62% women; median age 53 years; median 2 prior lines of therapy) with FGFR2 fusions/translocations were included…. Infigratinib-associated toxicity is manageable, and our efficacy findings suggest clinically meaningful activity after chemotherapy in pts with IHC containing FGFR2 fusions. The efficacy of infigratinib in this study supports FGFR2 as a therapeutic target in FGFR2-fusion IHC.
DOI:
10.1093/annonc/mdy424.030
Trial ID: