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 is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01035229

First received: December 17, 2009

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 17, 2009

Last Updated Date

April 8, 2013

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Overall Survival [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01035229 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Carcinoma

Intervention ^ICMJE

Drug: Everolimus

3 tablets a da for one year

Other Name: RAD001

Study Arm (s)

Experimental: Everolimus plus Basic Supportice Care
Intervention: Drug: Everolimus
Placebo Comparator: Placebo plus Basic Supportive Care
Intervention: Drug: Everolimus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

761

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Spain, Taiwan, Thailand

Administrative Information

NCT Number ^ICMJE

NCT01035229

Other Study ID Numbers ^ICMJE

CRAD001O2301, 2009-010196-25

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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