RAD001 in Advanced Hepatocellular Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||January 2010|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|