Phase 2
N=160
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Islet Cell Carcinoma · Neuroendocrine Carcinoma · Neuroendocrine Tumor · Pancreatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00363051 ↗Enrolled (actual)
160
Serious AEs
56.3%
Results posted
Mar 2012
Primary outcome: Primary: 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) — 9.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus 10 mg (Drug); Octreotide Depot (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
9.6 | — |
| SECONDARY Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review |
10.64 | — |
| SECONDARY Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review |
— | — |
| SECONDARY Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
4.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1] |
115; 10; 63 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2] |
45; 2; 27 | — |
| SECONDARY Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1) |
9.69 | — |
| SECONDARY Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2) |
16.69 | — |
| SECONDARY Time to Overall Survival (OS)(Stratum 1) |
28.78 | — |
| SECONDARY Time to Overall Survival (OS) (Stratum 2) |
38.77 | — |
| SECONDARY Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2) |
15.7; 17.3 | — |
| SECONDARY Effect of Octreotide Depot on the Trough Concentrations of Everolimus |
3.2; 3.7 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00363051). 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.