Imatinib in combination with phosphoinositol kinase inhibitor buparlisib in patients with gastrointestinal stromal tumour who failed prior therapy with imatinib and sunitinib: a Phase 1b, multicentre study.

British Journal of Cancer
Hans GelderblomPatrick Schӧffski

Abstract

The majority of patients with advanced gastrointestinal stromal tumours (GISTs) develop resistance to imatinib and sunitinib, the standard of care for these patients. This study evaluated the combination of buparlisib, an oral phosphoinositide 3-kinase (PI3K) inhibitor, with imatinib in patients with advanced GIST, who have failed prior therapy with imatinib and sunitinib. This Phase 1b, multicentre, open-label study aimed to determine the maximum tolerated dose (MTD) and/or a recommended Phase 2 dose of buparlisib in combination with 400 mg of imatinib through a dose-escalation part and a dose-expansion part, and also evaluated the clinical profile of the combination. Sixty patients were enrolled, including 25 in the dose-escalation part and 35 in the dose-expansion part. In the combination, MTD of buparlisib was established as 80 mg. No partial or complete responses were observed. The estimated median progression-free survival was 3.5 months in the expansion phase. Overall, 98.3% of patients had treatment-related adverse events (AEs), including 45% with grade 3 or 4 AEs. Buparlisib in combination with imatinib provided no additional benefit compared with currently available therapies. Due to the lack of objective responses, f...Continue Reading

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Citations

May 29, 2020·Current Treatment Options in Oncology·Sheima FaragRobin L Jones
Jan 22, 2021·Therapeutic Advances in Medical Oncology·M Julia Lostes-BardajiCésar Serrano
Jan 7, 2021·Journal of Hematology & Oncology·Ciara M KellyPing Chi
Apr 4, 2021·International Journal of Molecular Sciences·Rosalin MishraJoan T Garrett

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Methods Mentioned

BETA
surgical resection
xenograft
xenografts

Clinical Trials Mentioned

NCT01151852

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