- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278810
Phase I Study of Novel Estrogen Receptor(ER) a36 Modifier Icaritin in Advanced Breast Cancer Patients
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 Overview
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100021
- Recruiting
- Cancer Institute & Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Ying Fan, MD
- Phone Number: +86 010-87788120
- Email: fanying@csco.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female, age ≥ 18 years old and ≤ 65 years old
- The patients with advanced breast tumors who are confirmed through histologic or cytologic diagnosis with ER positive or investigator think that subjects will benefit from the trial
- The advanced breast cancer patients which relapse or failure from previous standard treatment
- 19 ≤ BMI index ≤ 30
- No serious heart, liver,lung and kidney diseases
- Received at least once anti-cancer treatment (including chemotherapy, radiotherapy, biological or endocrine treatment). And the last treatment must be at least four weeks before study enrollment or more than 5 times half life. The surgery treatment must be more than three months
- Life expectancy of at least 12 weeks
- Patients which can cooperate to observe AE and efficacy
- No any other concurrent anti-cancer treatment
- A signed informed consent must be obtained prior to performing any study specific procedures
- ECOG Performance Status of 0,1
- Female:Women with childbearing potential must have a negative pregnancy test performed
Exclusion Criteria:
- Have a known hypersensitivity to flavonoid drugs
Hepatic:
- ALB >limit if normal
- TB> the upper limit of normal
- ALT and AST > upper limit of Normal
Renal:
- Serum Creatinine > 1.5 times the upper limit of normal
Bone marrow:
- Absolute neutrophil count (ANC) < 1.5 × 109/L
- Platelet count < 90 × 109/L
- Hemoglobin < 9 g/dL
- PT/APTT > 1.25 times the upper limit of normal
- Suffered from thrombotic disease
- Serum Ca > the upper limit of normal
- Not recovered from toxic effects of previous anti-cancer treatments or surgery
- Any serious or uncontrollable concomitant systemic disorder (such as unstable respiratory disorders, cardiovascular, hepatic or kidney disorders.) or active infection which will influence the clinical trial
- CNS metastases or invade requiring treatment for unstable status or various psychiatric disorders
- No malabsorption or other disease which will affect the drug absorption,distribution,metabolism and excretion
- Concurrent other malignancies with the exception of cervical cancer in situ or squamous Cell Carcinoma of the Skin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Icaritin
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1-2 YEAR
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess pharmacokinetic profile of icaritin in breast cancer patients
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Binghe Xu, MD, Cancer institute & hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG0929ICR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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