Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

This study is ongoing, but not recruiting participants.

First Received: August 2, 2006 Last Updated: November 24, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00363051

Purpose

The purpose of this study is to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients will be treated with everolimus until either tumor progression is documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurs, or until the patient or investigator requests discontinuation of treatment.

Condition	Intervention	Phase
Islet Cell Carcinoma Neuroendocrine Carcinoma Neuroendocrine Tumor Pancreatic Neoplasms	Drug: Everolimus	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Stratified, Single-Arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Effect of everolimus on decreasing tumor size

Secondary Outcome Measures:

Duration of everolimus on tumor size
Effect of everolimus in combination with octreotide acetate on decreasing tumor size
The type, number and severity of side effects of everolimus alone,or everolimus in combination with octreotide acetate
Tracking the amount of everolimus in the blood over time and if it changes when given in combination with octreotide acetate for injection

Estimated Enrollment:	144
Study Start Date:	June 2006

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) biopsy-proven pancreatic NET
Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
Objective disease progression by RECIST criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
Presence of at least one measurable disease using RECIST criteria at screening (CT or MRI)
Adequate bone marrow, liver and kidney function

Exclusion criteria

Patients with poorly differentiated neuroendocrine carcinoma
Hepatic artery embolization within the last 6 months
Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
Other concurrent malignancy
Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363051

Show 27 Study Locations

Sponsors and Collaborators

Novartis

More Information

Additional Information:

RAD2239

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRAD001C2239
Study First Received:	August 2, 2006
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00363051 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Pancreatic
Tumor
Islet Cell
Carcinoma
Neuroendocrine

Endocrine
Atypical Carcinoid
RADIANT1
RADIANT-1

Study placed in the following topic categories:

Everolimus
Pancreatic Islet Cell Tumors
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Carcinoma, Islet Cell
Endocrine System Diseases
Immunosuppressive Agents
Carcinoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Digestive System Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Endocrinopathy
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Everolimus
Neoplasms by Histologic Type
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Carcinoma, Islet Cell
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Endocrine System Diseases
Immunosuppressive Agents
Pharmacologic Actions

Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplasms, Germ Cell and Embryonal
Pancreatic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009