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Efficacy and Safety of Everolimus (RAD001) in Female or Male Patients 18 Years or Older With Advanced Neuroendocrine Tumors
This study is currently recruiting participants.
Verified by Novartis, November 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00510068
  Purpose

The purpose of this study is to evaluate progression free survival in those assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors


Condition Intervention Phase
Advanced Neuroendocrine Tumors
Drug: Everolimus
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Everolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Double-Blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assess the clinical activity of everolimus plus best supportive care as defined by progression free survival, per Response Evaluation Criteria In Solid Tumors (RECIST) criteria, in patients with advanced Neuroendocrine Tumors.

Secondary Outcome Measures:
  • To evaluate the effect of everolimus on other tumor endpoints: objective response rate (Complete Response [CR] and Partial Response [PR]), response duration To compare overall survival (OS) between the study arms

Estimated Enrollment: 392
Study Start Date: July 2007
  Eligibility

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

Inclusion criteria:

  1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
  2. Measurable disease by radiologic assessment
  3. Adequate blood work
  4. Performance Status 0-2 : Ability to be out of bed most of the time
  5. Adult male or female patients ≥ 18 years of age
  6. Women of childbearing potential must have a negative serum pregnancy test
  7. Written informed consent from patients must be obtained in accordance to local guidelines

Exclusion criteria:

  1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma) cancer are not eligible
  2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial
  3. Hepatic artery procedure called embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment
  4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus, temsirolimus, everolimus).
  5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled medical conditions such as:
  6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
  7. Patients with a known history of HIV seropositivity
  8. No other prior or concurrent cancer at the time enrolling to this trial

Other protocol defined inclusion/ exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510068

Contacts
Contact: Novartis US 1 800 340 6843
Contact: Novartis Basel 41 61 324 1111

  Show 20 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: CRAD001C2324
Study First Received: July 31, 2007
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00510068  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Phase III
Advanced Neuroendocrine Tumor in adults
RAD001
NET

Study placed in the following topic categories:
Everolimus
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Neuroendocrine Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009