Spots Global Cancer Trial Database for A Phase Ib Study to Assess Safety and Efficacy of Oral Icaritin in Advanced Solid Tumors

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Trial Identification

Brief Title: A Phase Ib Study to Assess Safety and Efficacy of Oral Icaritin in Advanced Solid Tumors

Official Title: A Phase Ib ,Single Center, Open-labeling, Multiple Oral Dose Study to Assess the Safety, Tolerability，PK and Efficacy Profile for Advanced Solid Tumor Patients in China

Study ID: NCT02496949

Conditions

Solid Tumors

Interventions

Icaritin

Study Description

Brief Summary: to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of Icaritin in advanced solid tumor patients in China

Detailed Description: Estrogen receptor,ERa36, predominantly localizes on the plasma membrane and in the cytoplasm and mediates a membrane-initiated "nongenomic" signaling pathway. Membrane-initiated estrogen signaling has been linked to rapid responses to estrogen and generally activates signaling pathways like the mitogen-activated protein kinase/extracellular signal-regulated kinases (MAPK/ERK), phosphatidylinositol-3-kinase, and protein kinase C pathways. Preclinical study demonstrated that ERa36 was expressed in tumor cells and might be the driving force of breast cancer cell proliferation. 40% of breast cancer tumors which used to be considered as ER negative also express ERa36. In the former study the investigators found that 40% of ERa66-positive breast cancer patients express high levels of ERa36 in their tumors, and this subset of patients are less likely to benefit from tamoxifen treatment compared with those with ERa66-positive/ERa36-negative tumors. Icaritin is a newly discovered small molecule with selective ERa36 modulating capability and the potential as a very promising new drug to treat advanced breast cancer and hepatocellular carcinoma (HCC) by targeting this nongenomic pathway. Studies showed that it can inhibit the growth of cancer cells both in vitro and in vivo. The investigators have completed the preclinical pharmacokinetic, pharmacodynamic (PK\&PD) and toxicity studies in animals and now move on to test it in a phase Ib clinical trial.