Clinical trial · Interventional
Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)
Everolimus and Temozolomide as 1-line Treatment in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3) With a Ki67 of 20-55%
NCT02248012CI-TRIAL-00042429completedPhase 2ClinicalTrials.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)
To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus , temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus/temozolomide
- description
- Everolimus 10 mg daily, temozolomide 150 mg/m2 for 7 days every 2 weeks.
- interventionNames
- Drug: Everolimus , temozolomide
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Number of patients with adverse events
- timeFrame
- During treatment + 30 days
- description
- Especially number of patients with grade 3-4 toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria Histologically proven neuroendocrine carcinoma with a Ki67 of 20-55%.Primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominalMeasurable disease according to RECIST by CT/MR General conditions: * \>18 years; * WHO/ECOG performance status 0-1. * Adequate haematological, renal and hepatic functions: * Written informed consent prior to inclusion Prior therapy: * No prior chemotherapy treatment for advanced disease. * Adjuvant chemotherapy must have ended \> 6 months before inclusion. Prior or current history: * No curatively resectable disease; * No other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression ) Concomitant treatments : * No concomitant (or within 4 weeks before inclusion) administration of any other experimental drug; * No other concurrent anti-cancer therapy. Other : * Not pregnant or breast feeding. Fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test.
References
Publications (1)
- BACKGROUNDSorbye H, Strosberg J, Baudin E, Klimstra DS, Yao JC. Gastroenteropancreatic high-grade neuroendocrine carcinoma. Cancer. 2014 Sep 15;120(18):2814-23. doi: 10.1002/cncr.28721. Epub 2014 Apr 25. PMID 24771552