Evidence Level:Sensitive: C2 – Inclusion Criteria
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) [ Time Frame: 23 months ]
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:Adult patients were treated with escalating dosages of BGJ398 5 to 150 mg once daily or 50 mg twice daily continuously in 28-day cycles...10 of 32 patients (31%) with breast cancer treated at ≥ 100 mg had a best response of SD. Of 26 patients with breast cancer (FGFR1/2 amplified [n = 25]; FGFR3 mutant [n = 1]) with pre- and post-treatment target lesion measurements, four (15.4%) had reduced tumor burden...
DOI:10.1200/JCO.2016.67.2048