RAD001 in Advanced Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT00516165|
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : February 7, 2017
Last Update Posted : February 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: RAD001||Phase 1 Phase 2|
- Participants will be given a supply of the study drug RAD001 to be taken at home. They will be asked to take the study drug every morning on an empty stomach and will be given a study drug diary to record the time/date each time they take RAD001. Each 6 week period of time is called a cycle of study treatment.
- We are looking for the highest dose of RAD001 that can be given safely. Therefore not every participant will receive the same dose of RAD001.
- Participants will come to the clinic every other week. At each of these visits, a physical examination and blood tests will be performed.
- A CT and MRI will be repeated every 6 weeks during the first 3 cycles of treatment then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||November 2011|
Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.
Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days
Other Name: Everolimus
- Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC). [ Time Frame: 2 years ]
- Progression-free Survival Rate at 24 Weeks [ Time Frame: 2 years ]
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
This information will be collected during two years of patient participation.
- Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC [ Time Frame: 2 years ]Everolimus given at 10 mg/day as a single agent was well tolerated in patients with advanced HCC.
- Overall Response Rate [ Time Frame: 2 years ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Time to Progression [ Time Frame: 2 years ]3.9 months with a CI of 21-
- Overall Survival [ Time Frame: 2 years ]The median overall survival was 8.4 months (95% CI, 3.9-21.1 months). Only 2 ((8 %) patients were progression-free at 24 weeks. The study did not proceed to the second stage of the phase 2 portion of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516165
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Andrew X. Zhu, MD, PhD||Massachusetts General Hospital|