Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00412061

Purpose

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.

Condition	Intervention	Phase
Carcinoid Tumor Malignant Carcinoid Syndrome	Drug: Octrotide with Everolimus Drug: Octrotide depot with placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Carcinoid Tumors

Drug Information available for: Sirolimus Octreotide acetate Octreotide Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	390
Study Start Date:	December 2006
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sandostatin LAR® depot with RAD001	Drug: Octrotide with Everolimus
Placebo Comparator: Sandostatin LAR® depot with placebo	Drug: Octrotide depot with placebo

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412061

Show 48 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-12. Epub 2011 Nov 25.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00412061 History of Changes
Other Study ID Numbers:	CRAD001C2325
Study First Received:	December 13, 2006
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cancer
Carcinoid
Tumor
Neuroendocrine

Carcinoma
Everolimus
Octreotide

Additional relevant MeSH terms:

Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning
Substance-Related Disorders

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

ClinicalTrials.gov processed this record on February 12, 2012