Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma. (EVOLVE-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01035229
First received: December 17, 2009
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma
Drug: Everolimus
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression (TTP) [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient ] [ Designated as safety issue: No ]
  • Disease control rate (DCR) [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient ] [ Designated as safety issue: No ]
  • Change in Eastern Cooperative Oncology Group (ECOG) performance status over time [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient. ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient. ] [ Designated as safety issue: Yes ]
  • Change in quality of life (QoL) scores over time [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient. ] [ Designated as safety issue: No ]
  • Pharmacokinetics assessments [ Time Frame: Until all patients have disease progression or leave study due to intolerable advese events- Estimate of 1 year for each patient. ] [ Designated as safety issue: No ]

Enrollment: 546
Study Start Date: April 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus plus Basic Supportice Care Drug: Everolimus
3 tablets a da for one year
Other Name: RAD001
Placebo Comparator: Placebo plus Basic Supportive Care Drug: Everolimus
3 tablets a da for one year
Other Name: RAD001

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035229

  Show 131 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01035229     History of Changes
Other Study ID Numbers: CRAD001O2301, 2009-010196-25
Study First Received: December 17, 2009
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration
Austria: Ethikkommission
Belgium: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: Institutional Ethics Committee
Greece: Ethics Committee
Italy: Ethics Committee
Germany: German Institute of Medical Documentation and Information
Spain: Ministry of Health
Sweden: Institutional Review Board
Canada: Health Canada
Japan: Institutional Review Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Ethics Committee
Hong Kong: Department of Health
Korea: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Novartis:
Hepatocellular carcinoma
randomized trial
medical treatment
RAD001
placebo
Advanced Hepatocellular Carcinoma (HCC)

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014