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Status unknownNCT01278810Updated Jan 28, 2011

Phase I Study of Novel Estrogen Receptor(ER) a36 Modifier Icaritin in Advanced Breast Cancer Patients

A Phase 1 interventional study of Icaritin in Metastatic Breast Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-01-28.

Sponsored by Chinese Academy of Medical Sciences · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

To assess safety, tolerance and PK profile of different doses(50mg,100mg,200mg,300mg, 400mg, 500mg,QD)of Icaritin in advanced breast cancer Patients in China

Read the 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.

02

Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • Icaritin,
  • ERa36
03

In context

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female, age ≥ 18 years old and ≤ 65 years old
  2. 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
  3. The advanced breast cancer patients which relapse or failure from previous standard treatment
  4. 19 ≤ BMI index ≤ 30
  5. No serious heart, liver,lung and kidney diseases
  6. 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
  7. Life expectancy of at least 12 weeks
  8. Patients which can cooperate to observe AE and efficacy
  9. No any other concurrent anti-cancer treatment
  10. A signed informed consent must be obtained prior to performing any study specific procedures
  11. ECOG Performance Status of 0,1
  12. Female:Women with childbearing potential must have a negative pregnancy test performed

Exclusion criteria

Exclusion Criteria:

  1. Have a known hypersensitivity to flavonoid drugs

  2. 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
  3. PT/APTT > 1.25 times the upper limit of normal
  4. Suffered from thrombotic disease
  5. Serum Ca > the upper limit of normal
  6. Not recovered from toxic effects of previous anti-cancer treatments or surgery
  7. 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
  8. CNS metastases or invade requiring treatment for unstable status or various psychiatric disorders
  9. No malabsorption or other disease which will affect the drug absorption,distribution,metabolism and excretion
  10. Concurrent other malignancies with the exception of cervical cancer in situ or squamous Cell Carcinoma of the Skin
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Icaritin

    Drug: Icaritin

Interventions

  • DrugIcaritin

    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

    Also known as: IC-162

06

What researchers measure

Primary outcomes

  1. To assess safety of icaritin in breast cancer patients

    to find the dose-limiting toxicity(DLT)and maximal tolerated dose(MTD)of icaritin in breast cancer patients

    Time frame: 1-2 YEAR

Secondary outcomes

  1. To assess pharmacokinetic profile of icaritin in breast cancer patients

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Cancer institute & hospital, chinese academy of medical sciences
    Beijing, Beijing 100021, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01278810
Lead sponsor
Chinese Academy of Medical Sciences
Collaborators
Beijing Shenogen Biomedical Co., Ltd
First posted
Jan 19, 2011
Start date
Nov 2010
Primary completion
Nov 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Jan 28, 2011

Study contacts

Binghe Xu, MD
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Binghe Xu, MD
principal investigator · Cancer institute & hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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