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RAD001 in Advanced Hepatocellular Carcinoma

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007

Sponsors and Collaborators: Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00516165
  Purpose

Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently, the study drug is being tested in medical conditions in which excessive cell multiplication (as in cancer) needs to be stopped. The main purpose of this research study is to find the highest dose of RAD001 that can be given safely (without causing severe side effects) and to learn the effects (good or bad) RAD001 has on participants with liver cancer.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: RAD001
Phase I
Phase II

MedlinePlus related topics:   Cancer    Liver Cancer   

ChemIDplus related topics:   Everolimus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase I/II Study of RAD001 in Advanced Hepatocellular Carcinoma

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of RAD001 in patients with advanced hepatocellular carcinoma (HCC). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine progression-free survival rate at 24 weeks [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and toxicity of RAD001 in patients with HCC [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To assess the response rate and duration of response of RAD001 iin HCC, time to tumor progression, and overall survival of this population [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   August 2007
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: RAD001
    Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days
Detailed Description:
  • 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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Unresectable of metastatic HCC. Patients must have prior core biopsy to confirm the diagnosis of HCC and have archived tissues available for correlative studies
  • At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If it has had previous radiation to teh marker lesion(s), there must be evidence of progression since the radiation
  • 0-2 prior systemic chemotherapy and biologic regimens for hepatocellular carcinoma
  • Patients with prior chemoembolization history can participate in the study if the chemoembolization was performed more than 4 weeks ago and patients must have measurable disease outside of prior chemoembolization field
  • 18 years of age or older
  • Minimum of 4 weeks since any major surgery or completion of radiation
  • Minimum of 4 weeks since completion of all prior systemic anticancer therapy
  • ECOG performance status of 0-2
  • CLIP score of equal to or less then 3
  • Adequate bone marrow, liver and renal function as outlined in the protocol

Exclusion Criteria:

  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Patients with any severe and/or uncontrolled medical conditions or other condition that could affect participation in the study
  • Known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
  • Active, bleeding diathesis
  • Women who are pregnant or breast feeding
  • Patients who have received prior treatment with an mTor inhibitor
  • Patients with known hypersensitivity to RAD001 or other rapamycins or its excipients
  • History of non-compliance to medical regimens
  • Patients with a positive dipstick for urine protein (reading of 2+ or greater) will then undergo a 24-hour urine collection for protein. If patients have a 2g or greater of protein/24hr, they will be excluded from the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516165

Contacts
Contact: Andrew X Zhu, MD, PhD     617-724-0786     azhu@partners.org    

Locations
United States, Massachusetts
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States, 02114
      Principal Investigator: Andrew X. Zhu, MD, PhD            
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Principal Investigator: Charles Fuchs, MD            
Beth Israel Deaconess Medical Center     Recruiting
      Boston, Massachusetts, United States, 02215
      Principal Investigator: Sanjay Jain, MD, PhD            

Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis

Investigators
Principal Investigator:     Andrew X. Zhu, MD, PhD     Massachusetts General Hospital    
  More Information


Responsible Party:   Massachusetts General Hospital ( Andrew Zhu, MD )
Study ID Numbers:   06-352
First Received:   August 13, 2007
Last Updated:   December 28, 2007
ClinicalTrials.gov Identifier:   NCT00516165
Health Authority:   United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
liver cancer  
RAD001  

Study placed in the following topic categories:
Everolimus
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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