Clinical trial · Interventional
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
NCT00363051CI-TRIAL-00010255completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Islet Cell Carcinoma | Pancreatic Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumor | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus 10 mg | Drug | Everolimus | ALIAS |
| Octreotide Depot | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus 10 mg
- description
- Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
- interventionNames
- Drug: Everolimus 10 mg
- Drug: Octreotide Depot
Primary outcomes (1)
- measure
- Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
- description
- Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria for both strata: * Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET) * Confirmed low-grade or intermediate-grade neuroendocrine carcinoma * Objective disease progression by Response Evaluation Criteria in Solid tumors (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 (computer tomography \[CT\] or Magnetic resonance imaging \[MRI\]) * Adequate bone marrow, liver and kidney function * WHO Performance Status 0-2. Inclusion criteria for Stratum 2 only: * Meet all inclusion criteria defined above for both strata. * Receiving treatment (at least 3 consecutive months) with Octreotide Depot. * In addition to documentation of progressive disease on or after chemotherapy, patients in stratum 2 must have documented objective progression of disease while receiving Octreotide Depot. Exclusion criteria for both strata: * Anticancer therapy within 3 weeks of enrollment. * 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 Exclusion Criterion for Stratum 1 only: • Received treatment with Octreotide Depot or any other long-acting somatostatin analogue in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two weeks prior to enrollment. Other protocol-defined inclusion/exclusion criteria applied.
References
Publications (0)
Data not yet available
No reference posted for this study.