Solid Tumor Clinical Trial
Official title:
Phase1b/2 Study of AZD8186 in Combination With Paclitaxel in Patients With Advanced Gastric Cancer
AZD8186 is an orally-dosed, selective Phosphatidylinositol 3-kinase (PI3K) β/δ inhibitor that
binds to PI3Kβ and PI3Kδ, and inhibits kinase activity and downstream pathways in vitro and
in vivo. AZD8186 has shown significant anti-tumor activity in PTEN-deficient preclinical
models, including prostate, triple negative breast cancer, squamous lung and germinal center
diffuse large B-cell lymphoma models. PTEN deficiency is reported in approximately 20% of
patients with gastric cancer and in 35-48% of those with human epidermal growth factor
receptor 2(HER2)-positive gastric cancer. To date, there have been no clinical trials with
AZD8186 alone or in combination with paclitaxel in advanced gastric cancer. Therefore, it is
very important to conduct clinical trials of combination therapy of AZD8186 and paclitaxel in
patients with metastatic/recurrent gastric cancer who have failed previous therapy, and to
identify the clinical factors and biomarkers that predict effects of the combination therapy.
The purpose of the study is to define the maximal tolerated dose (MTD) and recommended phase
2 dose (RP2D) of paclitaxel and AZD8186 combination therapy in patients with advanced tumors
and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line
therapy in patients with advanced gastric cancer with PTEN aberrations. This study is divided
into Phase 1b and Phase 2.
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