Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
NCT ID: NCT01035229
Last Updated: 2016-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
546 participants
INTERVENTIONAL
2010-04-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Everolimus + Best Supportice Care (BSC)
Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the investigational drug. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
Everolimus
Everolimus (labeled as RAD001) was formulated as tablets of 2.5 mg strength and blisterpacked in units of 10 tablets.
Best Supportive Care (BSC)
BSC was defined as drug or non-drug therapies, nutritional support, physical therapy or anything that the Investigator believed to be in the patient's best interest, but excluding other antineoplastic treatments. BSC administered to the patient throughout the study was to be reported on the Concomitant Medication/Significant Non-Drug Therapy electronic case report from (eCRF). Permitted BSC treatments during the study included, but were not limited to, the following: Pain medication to allow the patient to be as comfortable as possible, Bisphosphonates for bone metastases, Localized radiotherapy, for the treatment of pre-existing, painful bone metastases, Nutritional support or appetite stimulants (i.e. megestrol) as recommended by the Investigator, Oxygen therapy and blood products or transfusions
Placebo + Best Supportive Care
Placebo Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placeb Everolimus, all patients also received BSC as per normal local practice.
Everolimus Placebo
Everolimus Placebo matched to the everolimus 2.5 mg tablet strength was blister-packed in units of 10 tablets. Matching placebo tablets were formulated to be indistinguishable from the everolimus tablets. Everolimus placebo was taken as a daily oral dose of 7.5 mg and was defined as the control drug.
Best Supportive Care (BSC)
BSC was defined as drug or non-drug therapies, nutritional support, physical therapy or anything that the Investigator believed to be in the patient's best interest, but excluding other antineoplastic treatments. BSC administered to the patient throughout the study was to be reported on the Concomitant Medication/Significant Non-Drug Therapy electronic case report from (eCRF). Permitted BSC treatments during the study included, but were not limited to, the following: Pain medication to allow the patient to be as comfortable as possible, Bisphosphonates for bone metastases, Localized radiotherapy, for the treatment of pre-existing, painful bone metastases, Nutritional support or appetite stimulants (i.e. megestrol) as recommended by the Investigator, Oxygen therapy and blood products or transfusions
Interventions
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Everolimus
Everolimus (labeled as RAD001) was formulated as tablets of 2.5 mg strength and blisterpacked in units of 10 tablets.
Everolimus Placebo
Everolimus Placebo matched to the everolimus 2.5 mg tablet strength was blister-packed in units of 10 tablets. Matching placebo tablets were formulated to be indistinguishable from the everolimus tablets. Everolimus placebo was taken as a daily oral dose of 7.5 mg and was defined as the control drug.
Best Supportive Care (BSC)
BSC was defined as drug or non-drug therapies, nutritional support, physical therapy or anything that the Investigator believed to be in the patient's best interest, but excluding other antineoplastic treatments. BSC administered to the patient throughout the study was to be reported on the Concomitant Medication/Significant Non-Drug Therapy electronic case report from (eCRF). Permitted BSC treatments during the study included, but were not limited to, the following: Pain medication to allow the patient to be as comfortable as possible, Bisphosphonates for bone metastases, Localized radiotherapy, for the treatment of pre-existing, painful bone metastases, Nutritional support or appetite stimulants (i.e. megestrol) as recommended by the Investigator, Oxygen therapy and blood products or transfusions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior systemic treatment with sorafenib for advanced HCC and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. Specifically, this can be defined as:
* Documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
* Intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.
NOTE:
* Sorafenib must be the last antineoplastic treatment before randomization
* Prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
* One systemic chemotherapy regimen for advanced HCC is allowed before sorafenib treatment
* ECOG performance status of ≤ 2
* Child-Pugh A
Exclusion Criteria
* Prior therapy with mTOR inhibitors
* Prior liver or other organ transplantation which mandates systemic immunosuppression
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
Compassionate Cancer Care Medical Group CCCMG
Fountain Valley, California, United States
University of California San Diego - Moores Cancer Center SC - 3
La Jolla, California, United States
California Pacific Medical Center California Pacific Med
San Francisco, California, United States
Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4)
Greenwood Village, Colorado, United States
Queen's Medical Center Queens Cancer Center
Honolulu, Hawaii, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
Baltimore, Maryland, United States
Massachusetts General Hospital Dept. of Mass General Hospital
Boston, Massachusetts, United States
Midwest Cancer Care Physicians Research Medical Center
Kansas City, Missouri, United States
VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS
Reno, Nevada, United States
University of Rochester Medical Center Rochester
Rochester, New York, United States
Northwest Cancer Specialists Rose Quarter Cancer Center
Portland, Oregon, United States
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)
Bethlehem, Pennsylvania, United States
Texas Cancer Center - Abilene
Abilene, Texas, United States
Methodist Charlton Cancer Center Methodist
Dallas, Texas, United States
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)
Dallas, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio
San Antonio, Texas, United States
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care
Roanoke, Virginia, United States
University of Washington Cancer Care SC
Seattle, Washington, United States
Novartis Investigative Site
Camperdown, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
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Graz, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Nanjing, Jiangsu, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Guangzhou, , China
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Amiens, , France
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Avignon, , France
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Bordeaux, , France
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Caen Cedex9, , France
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Chambray-lès-Tours, , France
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Clermont-Ferrand, , France
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Clichy, , France
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Dijon, , France
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Lille, , France
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Lyon, , France
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Marseille Cédex 5, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Reims, , France
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Rouen, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Mannheim, Baden-Wurttemberg, Germany
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Berlin, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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München, , Germany
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Würzburg, , Germany
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Thessaloniki, Greece, Greece
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Athens, GR, Greece
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Larissa, GR, Greece
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Benevento, BN, Italy
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Bologna, BO, Italy
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Foggia, FG, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Modena, MO, Italy
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Palermo, PA, Italy
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Padua, PD, Italy
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Aviano, PN, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Frattamaggiore, , Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Chiba, Chiba, Japan
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Kashiwa, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Iizuka, Fukuoka, Japan
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Gifu, Gifu, Japan
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Ōgaki, Gifu, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Sendai, Miyagi, Japan
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Osaka, Osaka, Japan
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Sayama, Osaka, Japan
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Chuo-ku, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Córdoba, Andalusia, Spain
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Sabadell, Barcelona, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Niaosong Township, Taiwan, Taiwan
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Taichung, Taiwan, Taiwan
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Tainan City, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, ROC, Taiwan
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Linkou District, , Taiwan
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Liouying Township, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
Countries
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References
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Zhu AX, Chen D, He W, Kanai M, Voi M, Chen LT, Daniele B, Furuse J, Kang YK, Poon RT, Vogel A, Chiang DY. Integrative biomarker analyses indicate etiological variations in hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):296-304. doi: 10.1016/j.jhep.2016.04.015. Epub 2016 Apr 27.
Zhu AX, Kudo M, Assenat E, Cattan S, Kang YK, Lim HY, Poon RT, Blanc JF, Vogel A, Chen CL, Dorval E, Peck-Radosavljevic M, Santoro A, Daniele B, Furuse J, Jappe A, Perraud K, Anak O, Sellami DB, Chen LT. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA. 2014 Jul 2;312(1):57-67. doi: 10.1001/jama.2014.7189.
Related Links
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Other Identifiers
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2009-010196-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001O2301
Identifier Type: -
Identifier Source: org_study_id
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