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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01035229

Public ClinicalTrials.gov record NCT01035229. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 10:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01035229
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
546 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2010 (Type not available)
Primary completion
Oct 2013 (Actual)
Completion
Oct 2013 (Actual)
Last update posted
Sep 22, 2016

2010 – 2013

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville Arkansas 72703 —
Compassionate Cancer Care Medical Group CCCMG Fountain Valley California 92708 —
University of California San Diego - Moores Cancer Center SC - 3 La Jolla California 92093-0658 —
California Pacific Medical Center California Pacific Med San Francisco California 94120-7999 —
Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4) Greenwood Village Colorado — —
Queen's Medical Center Queens Cancer Center Honolulu Hawaii 96817 —
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU Baltimore Maryland 21287-0013 —
Massachusetts General Hospital Dept. of Mass General Hospital Boston Massachusetts 02114 —
Midwest Cancer Care Physicians Research Medical Center Kansas City Missouri 64131 —
VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS Reno Nevada 89502 —
University of Rochester Medical Center Rochester Rochester New York 14642 —
Northwest Cancer Specialists Rose Quarter Cancer Center Portland Oregon 97210 —
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2) Bethlehem Pennsylvania — —
Texas Cancer Center - Abilene Abilene Texas 79606 —
Methodist Charlton Cancer Center Methodist Dallas Texas 75237 —
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3) Dallas Texas 75390-8527 —
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio San Antonio Texas 78229 —
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care Roanoke Virginia 24018 —
University of Washington Cancer Care SC Seattle Washington 98109-1023 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 112 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01035229, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 22, 2016 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01035229 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →