An open label randomized phase II study of pasireotide with or without everolimus in castrate-resistant chemotherapy-naïve prostate cancer patients

Jianqing Lin , Aileen Deng , Jean Hoffman-Censits , Geoffrey Gibney , Terry Hyslop , Brooke Miller , Deborah Kilpatrick , Serge Jabbour , William Kevin Kelly
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Abstract

New areas of research continue to examine the role of non-androgen receptor pathways in prostate cancer treatment. The phosphatidylinositol 3-kinase/Akt/mammalian target of rapamycin (mTOR) pathway may be a target for prostate cancer therapy. Somatostatin receptor signaling inhibits intracellular PI3K/Akt signaling, making it an attractive target for combination therapy. We conducted a phase II open label clinical trial examining the use of somatostatin receptor agonist, pasireotide (SOM230) in combination with mTOR inhibitor, everolimus in metastatic castrate-resistant chemotherapy-naïve prostate cancer patients. Of the 6 patients enrolled in the study, only 1 patient had >50% PSA reduction from baseline. Three patients withdrew due to grade 3 adverse events. The study was closed early due to toxicity profiles and no further development was planned for this combination treatment in prostate cancer.

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一项开放标签随机II期研究,pasireotide联合或不联合依维莫司治疗去势抵抗chemotherapy-naïve前列腺癌患者
新的研究领域继续研究非雄激素受体途径在前列腺癌治疗中的作用。磷脂酰肌醇3-激酶/Akt/哺乳动物雷帕霉素靶蛋白(mTOR)通路可能是前列腺癌治疗的靶点。生长抑素受体信号抑制细胞内PI3K/Akt信号,使其成为联合治疗的一个有吸引力的靶点。我们进行了一项II期开放标签临床试验,检查生长抑素受体激动剂pasireotide (SOM230)与mTOR抑制剂依维莫司联合用于转移性阉割抵抗chemotherapy-naïve前列腺癌患者。在参与研究的6名患者中,只有1名患者的PSA较基线降低了50%。3例患者因3级不良事件退出治疗。由于毒性分析,该研究提前结束,并且没有计划进一步开发这种联合治疗前列腺癌的方法。
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