Solid Tumors Clinical Trial
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
to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of Icaritin in advanced solid tumor patients in China
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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||
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