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

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01035229

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:

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

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 ]

Estimated Enrollment:	531
Study Start Date:	April 2010
Estimated Primary Completion Date:	March 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:

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

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

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

Contacts

Contact: Novartis Pharmaceuticals

+1(800)340-6843

Show 168 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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:	March 13, 2012
Health Authority:	United States: Food and Drug Administration Austria: Ethikkommission Belgium: Institutional Review Board France: Afssaps - French Health Products Safety Agency 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
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Everolimus

Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2012