Status:
COMPLETED
Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced NET of GI Origin
Advanced NET of Lung Origin
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrin...
Detailed Description
This was a prospective, multi-center, randomized, double-blind, parallel-group, placebo-controlled, two-arm Phase III study comparing the efficacy and safety of everolimus 10 mg daily to placebo in pa...
Eligibility Criteria
Inclusion
- Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of GI or lung origin
- No history of and no active symptoms related to carcinoid syndrome
- In addition to treatment-naive patients, patients previously treated with SSA, Interferon (IFN), one prior line of chemotherapy, and/or PRRT were allowed into the study. Pretreated patients had to have progressed on or after the last treatment
- Radiological documented disease progression within 6 months prior to randomization
- Measurable disease
- WHO performance status ≤1
- Adequate bone marrow, liver and renal function
Exclusion
- Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma
- Patients with pancreatic NET or NET of origins other than GI or Lung
- Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing, diarrhea)
- Patients with more than one line of prior chemotherapy
- Prior targeted therapy
- Hepatic intra-arterial embolization within the last 6 months. Cryoablation or radiofrequency ablation of hepatic metastases within 2 months of randomization
- Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus)
- Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus)
- Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
- Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy
- Patients who had any severe and/or uncontrolled medical conditions such as:
- unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia
- active or uncontrolled severe infection
- liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA)
- Chronic treatment with corticosteroids or other immunosuppressive agents
- Known history of HIV seropositivity
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria might apply.
Key Trial Info
Start Date :
March 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01524783
Start Date
March 30 2012
End Date
August 7 2020
Last Update
August 5 2021
Active Locations (97)
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1
University of California San Diego - Moores Cancer Center Regulatory
La Jolla, California, United States, 92093-0658
2
Scripps Clinic Regulatory
La Jolla, California, United States, 92121
3
Cedars Sinai Medical Center SC
Los Angeles, California, United States, 90048
4
University of Colorado Cancer Centre SC
Aurora, Colorado, United States, 80045