Phase I Study of Novel Estrogen Receptor(ER) a36 Modifier Icaritin in Advanced Breast Cancer Patients
NCT01278810 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2011-01-28
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
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
Beijing Shenogen Biomedical Co., Ltd
collaborator INDUSTRY -
Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Binghe Xu, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Binghe Xu, MD · Cancer institute & hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2011-11-30
- Completion
- 2011-12-31
Countries
- China
Study Locations
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