A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer

Breast Cancer Research and Treatment
Vandana G AbramsonIan E Krop

Abstract

This open-label, phase Ib, dose-escalation, and dose-expansion study (NCT01862081) evaluated taselisib with a taxane in locally advanced or metastatic breast cancer (BC) and/or non-small cell lung cancer (NSCLC). Patients received taselisib (2-6 mg tablet or 3-6 mg capsule) plus docetaxel or paclitaxel. Primary endpoints were safety, dose-limiting toxicities, maximum tolerated dose, and identification of a recommended phase II dose. Secondary endpoints included pharmacokinetics and antitumor activity assessment. Eighty patients (BC: 72; NSCLC: 7; BC/NSCLC: 1) were enrolled (docetaxel-receiving arms: 21; paclitaxel-receiving arms: 59). Grade ≥ 3 adverse events (AEs), serious AEs, and AEs leading to death were reported in 90.5%, 42.9%, and 14.3% of patients, respectively (docetaxel-receiving arms), and 78.9%, 40.4%, and 3.5% of patients, respectively (paclitaxel-receiving arms). Eight patients experienced dose-limiting toxicities. The maximum tolerated dose was exceeded with 3 mg taselisib (capsule) for 21 consecutive days plus 75 mg/m2 docetaxel and not exceeded with 6 mg taselisib (tablet) for 5 days on/2 days off plus 80 mg/m2 paclitaxel. Objective response rates and clinical benefit rates were 35.0% and 45.0%, respectively (d...Continue Reading

References

May 16, 2000·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·F A ShepherdJ Berille
Mar 16, 2004·Science·Yardena SamuelsVictor E Velculescu
Sep 2, 2008·Cancer Research·Hiromasa YamamotoAdi F Gazdar
Sep 17, 2008·Oncogene·T L Yuan, L C Cantley
Jul 25, 2009·Nature Reviews. Cancer·Jeffrey A Engelman
Dec 14, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Johanna C BendellJosé Baselga
Sep 25, 2012·Nature·UNKNOWN Cancer Genome Atlas Network
Jan 1, 2012·Pharmaceuticals·Evangelos G SarrisKostas N Syrigos
Jan 24, 2014·The New England Journal of Medicine·Ajay K GopalGilles A Salles
Feb 1, 2014·Nature Reviews. Drug Discovery·David A Fruman, Christian Rommel
Jul 30, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Vicky S SabineJohn M S Bartlett
Nov 6, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Debashis SarkerJohann S de Bono
Oct 10, 2015·Cell·Giovanni CirielloCharles M Perou
Nov 3, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M MartínS Delaloge
May 23, 2017·Cancer Cell·Yiqun ZhangChad J Creighton
May 26, 2018·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Maura N DicklerJosé Baselga

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Citations

Apr 4, 2021·International Journal of Molecular Sciences·Rosalin MishraJoan T Garrett

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