Solid Tumors Clinical Trial
Official title:
A Phase Ib ,Single Center, Open-labeling, Multiple Oral Dose Study to Assess the Safety, Tolerability,PK and Efficacy Profile for Advanced Solid Tumor Patients in China
Verified date | July 2015 |
Source | Chinese Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
to assess the safety, tolerability,PK and efficacy profile of two doses (600mg,800mg,BID) of Icaritin in advanced solid tumor patients in China
Status | Completed |
Enrollment | 28 |
Est. completion date | August 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria: 1. age=18 years old and =65 2. The patients with advanced breast tumors,hepatocellular carcinoma (HCC) or other advanced solid tumor patients who are confirmed through histologic or cytologic diagnosis to be ER positive or subjects whom investigators believe may benefit from the trial. 3. Patients with advanced cancer that relapsed after or failed previous standard treatment 4. 19=BMI index=30 5. No serious heart, liver,lung and kidney diseases. 6. .Received at least one anti-cancer treatment (including chemotherapy, radiotherapy, biological or endocrine treatment). And the last treatment must be at least four weeks before study enrollment or after 5 times of the drug's half-life time has passed. The surgery treatment must be more than three months. 7. Life expectancy of at least 12 weeks. 8 .Patients who 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. The Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 12. Female:Women with childbearing potential must have a negative pregnancy test performed 13. HCC patients: Child-Pugh Class of A or B Exclusion Criteria: 1. Have a known hypersensitivity to flavonoid drugs. 2. Hepatic: 1. HCC patients : ALB <2.8g/dL, TB>3.0mg/dL, ALT and AST > 2.5 times the upper limit of Normal 2. Advanced breast tumors or other advanced solid tumor patients: ALB >limit of 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. Blood test: 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. HCC patients: PT > 5 seconds above control 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. Malabsorption or other disease which will affect the drug absorption,distribution,metabolism and excretion. 10. Other concurrent malignancies with the exception of cervical cancer in situ or squamous cell carcinoma of the skin . |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Cancer institute & hospital, chinese academy of medical sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences | Beijing Shenogen Biomedical Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients reported adverse events | 1-2 year | Yes | |
Secondary | Progression free survival | 1-2 Years | Yes | |
Secondary | Time to tumor progression | 1-2 Years | Yes | |
Secondary | Overall survival | 1-2 Years | Yes |
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