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Metastatic Breast CancerPhase 1NCT01278810

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

A Phase 1 study testing Icaritin in people with Metastatic Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Icaritin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Nov 2010to Dec 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Cancer institute & hospital, chinese academy of medical sciences

    Beijing, Beijing Municipality, 100021

    Ying Fan, MD, +86 010-87788120, fanying@csco.org.cn

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Icaritin
Keywords
Icaritin,, ERa36
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcaritinDrug

    Also called IC-162

    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

Study groups in NCT01278810
Study groupRoleWhat they receive
IcaritinExperimentalNot described
Receives: Drug: Icaritin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1-2 YEAR

Secondary outcomes (1)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01278810
Sponsor's protocol ID
TG0929ICR
Status last verified
Nov 2010
First submitted
18 Jan 2011
Last updated
28 Jan 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Icaritin in people with Metastatic Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess safety of icaritin in breast cancer patients (time frame: 1-2 YEAR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01278810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.

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