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A phase I/Ib study of crenolanib with ramucirumab (RAM)/paclitaxel (PTX) as second-line therapy (2L tx) for advanced esophagogastric adenocarcinoma (EGA)

Journal of Clinical Oncology Feb 03, 2019

Greally M, et al. - In this phase I/Ib study, researchers reported initial outcomes of the dose escalation phase of a study of crenolanib plus ramucirumab (RAM)/paclitaxel (PTX) in patients with previously treated advanced esophagogastric adenocarcinoma (EGA). Study participants included ECOG PS 0-1 EGA patients with progression on first-line chemo. For this investigation, PTX 80 mg/m2/ day on day 1, 8, 15 and RAM 8mg/kg q 14 days were administered with escalating doses of crenolanib (60, 80, 100 mg BID) after a 7 day “run-in” of crenolanib to evaluate crenolanib-related toxicities. On the basis of the data collected, it was concluded that crenolanib plus RAM/PTX seems well tolerated at a dose level of 100 mg BID for EGA patients. Fatigue, nausea, vomiting and hypertension were treatment-related adverse events.
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