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

NCT01278810 | Unknown Phase 1

• 1 other identifier: TG0929ICR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metastatic Breast Cancer

Keywords

Icaritin,; ERa36

Outcome Measures

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

  1-2 YEAR

Secondary Outcomes (1)

• To assess pharmacokinetic profile of icaritin in breast cancer patients

  1 year

Study Arms (1)

Icaritin

EXPERIMENTAL

Drug: Icaritin

Interventions

Icaritin DRUG

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

Icaritin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Beijing Shenogen Biomedical Co., Ltd: collaborator

Study Sites (1)

Cancer institute & hospital, chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

icaritin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Binghe Xu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Binghe Xu, MD

  Cancer institute & hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 28, 2011

Record last verified: 2010-11

Locations

CN (1)