Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma

Thank you

Trial Information

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


Inclusion Criteria:



1. Advanced liver cancer

2. 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

3. ECOG performance status of ≤ 2

4. Child-Pugh A

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient.

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001O2301

NCT ID:

NCT01035229

Start Date:

April 2010

Completion Date:

September 2013

Related Keywords:

  • Carcinoma
  • Hepatocellular carcinoma
  • randomized trial
  • medical treatment
  • RAD001
  • placebo
  • Advanced Hepatocellular Carcinoma (HCC)
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Texas Cancer Center - Abilene Abilene, Texas  79606
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio San Antonio, Texas  78229
Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville, Arkansas  72703
Compassionate Cancer Care Medical Group CCCMG Fountain Valley, California  92708
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  21231
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  
Methodist Charlton Cancer Center Methodist Dallas, Texas  75237
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3) Dallas, Texas  75390-8527
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care Roanoke, Virginia  24014
University of California San Diego SC - 3 La Jolla, California  92093-0658
University of Washington Cancer Care SC Seattle, Washington  98109-1023