A phase I pilot study of the insulin-like growth factor 1 receptor pathway modulator AXL1717 in combination with gemcitabine HCl and carboplatin in previously untreated, locally advanced, or metastatic non-small cell lung cancer

Medical Oncology
Georg HolgerssonMichael Bergqvist

Abstract

AXL1717 is an orally bioavailable IGF-1R pathway modulator that has been shown to have anti-tumoral effects. The objectives of the present study were to define maximum tolerated dose and the recommended phase II dose (RPTD) of AXL1717 in combination with gemcitabine HCl and carboplatin in non-small cell lung cancer (NSCLC). Patients with previously untreated, locally advanced, or metastatic NSCLC (squamous cell cancer or adenocarcinoma) in good performance status and with preserved major organ functions were enrolled in the study. The study was an open-label phase I study with planned cohorts of three patients per dose level of AXL1717 (215, 290, and 390 mg BID). In total, 12 patients were enrolled in the study, and of these, two were prematurely excluded. AXL1717 was administered at one dose level, 215 mg BID. A total number of 81 unique adverse events were reported. Bone marrow toxicity was reported in 10 out of 12 patients, and this organ class showed the largest number of related events. AXL1717 in combination with gemcitabine HCl and carboplatin is a possible treatment approach in previously untreated, locally advanced, or metastatic non-small cell lung cancer. However, due to the bone marrow toxicity profile shown in the ...Continue Reading

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Citations

Jul 26, 2019·Journal of Hematology & Oncology·Bhawana GeorgeHesham M Amin
Oct 27, 2017·Scientific Reports·Christabel WilsonJohn C Ashton
Sep 24, 2016·Oncotarget·Deeksha VishwamitraHesham M Amin
Nov 5, 2019·Frontiers in Oncology·Xuan ZhuXing Niu
Nov 24, 2020·Frontiers in Cell and Developmental Biology·Alyssa J CozzoStephen D Hursting

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