Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor - Tabular View

Tracking Information

First Received Date ^ICMJE

December 13, 2006

Last Updated Date

November 18, 2009

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression Free Survival (PFS)evaluated per central radiological assessment. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
To characterize the PK of RAD001 and Sandostatin LAR® depot administered in combinations [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Assess the clinical activity of everolimus plus octreotide as defined by progression free survival, per Response Evaluation Criteria In Solid Tumors (RECIST) criteria, in patients with advanced carcinoid tumor.

Change History

Complete list of historical versions of study NCT00412061 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate best overall response rand response reduction [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
T compare overall survival between study arms. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
To compare changes from baseline in 5-HIAA and chromogranin-A [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To determine the safety and tolerability of the combination of RAD001 plus Sandostatin LAR® depot. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Effect of everolimus on decreasing tumor size and related tumor endpoints (best overall response rate – complete response and partial response, response duration).
Effect of everolimus on overall survival.
Changes in tumor biomarkers caused by treatment.
Safety and tolerability of everolimus at 10 mg / day plus octreotide depot treatment regimen.

Descriptive Information

Brief Title ^ICMJE

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

Official Title ^ICMJE

A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

Brief Summary

The purpose of this study is to evaluate whether everolimus 10 mg / day added to treatment with octreotide depot prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoid Tumor
Malignant Carcinoid Syndrome

Intervention ^ICMJE

Drug: Octrotide with Everolimus
Drug: Octrotide depot with placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

390

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria

Advanced (unresectable or metastatic) carcinoid tumor
Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
Documented progression of disease within 12 months prior to enrollment.
Measurable disease determined by Triphasic CT scan or MRI.

Exclusion criteria

Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
Previous treatment with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
Severe or uncontrolled medical conditions
Chronic treatment with corticosteroids or other immunosuppressive agent.
Other primary cancer within 3 years.

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

Administrative Information

NCT ID ^ICMJE

NCT00412061

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CRAD001C2325

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

November 2009

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