Phase 3
N=429
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
Carcinoid Tumor · Malignant Carcinoid Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00412061 ↗Enrolled (actual)
429
Serious AEs
49.2%
Results posted
Mar 2012
Primary outcome: Primary: Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review — 16.43; 11.33 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octreotide (Drug); Placebo (Drug); Everolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review |
16.43; 11.33 | — |
| SECONDARY Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
2.3; 1.9 | — |
| SECONDARY Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level |
21.75; 13.90; 13.83; 8.41 | — |
| SECONDARY Overall Survival Using Kaplan-Meier Methodology |
80.5; 81.8; 57.0; 63.6; 42.9; 48.5 | — |
| SECONDARY Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase) |
208; 146; 162; 109; 19; 11 | — |
| SECONDARY Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase) |
154; 115; 22; 93 | — |
| SECONDARY Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA) |
31.31; 20.07; 13.93; 8.41 | — |
Summary
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.
Eligibility 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 randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (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 mammalian target of rapamycin (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 applied
Data sourced from ClinicalTrials.gov (NCT00412061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.