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RAD001 in Advanced Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00516165
First received: August 13, 2007
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Intervention: Drug: RAD001

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
RAD001

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.

RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days


Participant Flow:   Overall Study
    RAD001
STARTED   28 
COMPLETED   28 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
RAD001

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.

RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days


Baseline Measures
   RAD001 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Years]
Median (Full Range)
 65 
 (33 to 81) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  46.4% 
>=65 years      15  53.6% 
Gender 
[Units: Participants]
Count of Participants
 
Female      10  35.7% 
Male      18  64.3% 
Region of Enrollment 
[Units: Participants]
 
United States   28 


  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).   [ Time Frame: 2 years ]

2.  Primary:   Progression-free Survival Rate at 24 Weeks   [ Time Frame: 2 years ]

3.  Secondary:   Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC   [ Time Frame: 2 years ]

4.  Secondary:   Overall Response Rate   [ Time Frame: 2 years ]

5.  Secondary:   Time to Progression   [ Time Frame: 2 years ]

6.  Secondary:   Overall Survival   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr.Andrew X. Zhu
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: azhu@mgh.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00516165     History of Changes
Other Study ID Numbers: 06-352
Study First Received: August 13, 2007
Results First Received: December 3, 2014
Last Updated: December 14, 2016