Investigational New Drugs https://doi.org/10.1007/s10637-018-0601-1 PHASE I STUDIES Phase I dose-escalation trial of afatinib, an irreversible ErbB family blocker, in combination with gemcitabine or docetaxel in patients with relapsed or refractory solid tumors 1 2 3 4 5 Sandrine Hiret & Nicolas Isambert & Carlos Gomez-Roca & Jaafar Bennouna & Mouna Sassi & 5 6 7 3 Hélène de Mont-Serrat & Jean Fan & David Schnell & Jean-Pierre Delord Received: 29 November 2017 /Accepted: 5 April 2018 Springer Science+Business Media, LLC, part of Springer Nature 2018 Summary Background Afatinib, an irreversible ErbB family blocker, has shown synergistic antitumor activity and manageable tolerability in combination with chemotherapy. This phase I study assessed oral afatinib plus intravenous gemcitabine or docetaxel in patients with relapsed/refractory solid tumors. Methods Patients received afatinib (30, 40, or 50 mg) plus gemcitabine (1000 or 1250 mg/m )or docetaxel (60 or 75 mg/m ). Dose escalation proceeded via a 3 + 3 design until the maximum tolerated dose (MTD) was reached. Adverse events (AEs), pharmacokinetics and antitumor activity were also assessed. Results Dose-limiting toxicities during Cycle 1 were reported in 6/39 patients receiving afatinib/gemcitabine (most commonly diarrhea, thrombocytopenia and vomiting) and 16/54 patients receiving afatinib/docetaxel (most commonly febrile
Investigational New Drugs – Springer Journals
Published: May 29, 2018
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