Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma

In brief

The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

Key facts

Study ID

NCT01035229

Run by

Novartis Pharmaceuticals

People needed

546

Starts

2010-04-01

Expected to finish

2013-10-01

Last updated by the study team

2016-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Advanced liver cancer
• 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

You may not qualify if…

• Active bleeding during the last 28 days
• Prior therapy with mTOR inhibitors
• Prior liver or other organ transplantation which mandates systemic immunosuppression
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Novartis Investigative Site — Kogarah, New South Wales, Australia
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Graz, Austria
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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