Phase I Study of Novel Estrogen Receptor(ER) a36 Modifier Icaritin in Advanced Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01278810|
Recruitment Status : Unknown
Verified November 2010 by Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : January 19, 2011
Last Update Posted : January 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Icaritin||Phase 1|
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 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 molecular compound which is high selective ERa36 modulators and perhaps will be a very promising new drug to treat advanced breast cancer by targeting this nongenomic pathway. It was showed that it can inhibit the growth of breast cancer cells both in vitro and in vivo. The investigators have completed the preclinical PK&PD and toxicity studies in animals and now move on to test it in a FIM clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I ,Single Center, Open-labeling, Single and Dose-escalating Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Oral Novel ERa36 Modifier Icaritin in Advanced Breast Patients|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||December 2011|
50mg,100mg,200mg,300mg,400mg,500mg ascending-multiple oral dose, Qd, single dose and continuing dose 28 days, to assess the safety,tolerance and pharmacokinetics of icaritin
Other Name: IC-162
- To assess safety of icaritin in breast cancer patients [ Time Frame: 1-2 YEAR ]to find the dose-limiting toxicity(DLT)and maximal tolerated dose(MTD)of icaritin in breast cancer patients
- To assess pharmacokinetic profile of icaritin in breast cancer patients [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278810
|Cancer institute & hospital, chinese academy of medical sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Ying Fan, MD +86 010-87788120 firstname.lastname@example.org|
|Principal Investigator:||Binghe Xu, MD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Principal Investigator:||Binghe Xu, MD||Cancer institute & hospital|