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Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
This study is ongoing, but not recruiting participants.
First Received: December 13, 2006   Last Updated: September 21, 2009   History of Changes
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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:


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: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sandostatin LAR® depot with RAD001: Experimental Drug: Octrotide with Everolimus
Sandostatin LAR® depot with placebo: Placebo Comparator 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 Chair: Novartis Novartis
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CRAD001C2325
Study First Received: December 13, 2006
Last Updated: September 21, 2009
ClinicalTrials.gov Identifier: NCT00412061     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Cancer
Carcinoid
Tumor
Neuroendocrine
Carcinoma
Everolimus
Octreotide

Additional relevant MeSH terms:
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Disorders of Environmental Origin
Octreotide
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Syndrome
Therapeutic Uses
Everolimus
Neoplasms by Histologic Type
Disease
Antineoplastic Agents, Hormonal
Serotonin Syndrome
Poisoning
Gastrointestinal Agents
Malignant Carcinoid Syndrome
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Drug Toxicity
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009