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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: Beijing Shenogen Biomedical Co., Ltd

Criteria

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:

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