Status:
UNKNOWN
Randomized Phase I/II of RAD001 in Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Novartis
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The mTOR has been examined in hepatocellular carcinomas as well. This pathway is up-regulated in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits cell proliferation and block...
Detailed Description
Objectives： 1. Primary Objectives * Phase I: To assess the maximal tolerated dose (MTD) of once daily and weekly oral RAD001 in patients with advanced HCC of Child-Pugh's class A or B * Phase ...
Eligibility Criteria
Inclusion
- Patients with measurable, metastatic or locally advanced HCC that are not feasible to have or have failed to prior local therapy (including surgical resection, transarterial chemoembolization and/or alcohol injection) are eligible.
- The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies (have to including angiography) plus serum level of AFP equal to or more than 400 ng/mL in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
- Patients must be equal to or more than 20 years of age and equal or less than 75 years of age.
- Patients must have a performance status of ECOG score equal to or less than 2.
- Patients must fulfill all of the following criteria: Child-Pugh's Score equal to or less than 9; serum total bilirubin level is equal to or less than 2.0 mg/dL; serum ALT level (GPT) equal to or less than 3.0 x upper normal limit; platelet are equal to or more than 50,000 / uL; WBC are equal to or more than 3,000 / uL.
- Serum creatinine equal to or less than 2.0 x upper normal limit.
- Life expectancy equal to or more than 12 weeks.
- Signed informed consent.
- Sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after therapy.
- Female patients at child-bearing age must have negative pregnancy test.
- No known HIV infection.
Exclusion
- Patients with diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
- Patients with concomitant active secondary malignancies, except for surgically cured carcinoma in situ of the cervix and basal or adequately treated squamous cell carcinoma of the skin, or disease-free of malignancies \< 3 years before the study, are not eligible.
- Patients with active infection are not eligible.
- Patients who received other rapamycin analogs before are not eligible.
- Patients with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris or myocardiac infarction) and other systemic diseases under poor control are not eligible.
- Patients with history of psychiatric disorder are not eligible.
- Patients with brain metastases are not eligible.
- Patients who received surgery, radiotherapy except to bone, chemotherapy, immunotherapy, or other investigational drug within 4 weeks before initiating study are not eligible.
- Patients who are pregnant, breast-feeding or not using appropriate birth control during the course of the study are not eligible.
- Patients with significant concomitant disease that will be aggravated by the investigational drug are not eligible.
- Patients on active treatment with inhibitors or inducers of P-glycoprotein, CYP3A4 and CYP3A5 are not eligible; a minimal of 2 weeks wash-out period will be required after stop such medications.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00390195
Start Date
October 1 2006
End Date
June 1 2011
Last Update
July 2 2009
Active Locations (2)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, 704
2
Tri-Service General Hospital
Taipei, Taiwan, 11490