Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas
A Phase II/III Randomized Double-blind Study of Sandostatin LAR in Combination With Axitinib Versus Sandostatin LAR With Placebo in Patients With Advanced G1-G2 Neuroendocrine Tumours (WHO 2010) of Non-pancreatic Origin
Sponsor: Grupo Espanol de Tumores Neuroendocrinos
A observational or N/A phase clinical study on Advanced Cancer and Neuroendocrine Tumors, this trial is completed. The trial is conducted by Grupo Espanol de Tumores Neuroendocrinos and has accumulated 14 data snapshots since 2011. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)Phase II/III, prospective, multicenter, randomized (1:1), double-blind study to evaluate the efficacy and tolerability of axitinib in patients diagnosed with advanced G1-G2 neuroendocrine tumors (WHO 2010) of nonpancreatic origin that have presented documented disease progression in the 12 months prior to entering the study. In the first part of the study (Phase II), 105 patients were enrolled. The second part of the study is the expansion to Phase III, which is expected to include 148 additional patients. Patients will be randomized to receive Sandostatin LAR with axitinib or Sandostatin LAR with placebo until disease progression or unacceptable toxicity occurs. Randomization will be stratified by the time from diagnosis to enrollment in the study (more vs less than or equal to 12 months), the origin of the primary tumor (gastrointestinal tract vs non-gastrointestinal tract \[lung or other sites\]) and ki-67 (\< 5% vs \> 5%).
Phase II/III, prospective, multicenter, randomized (1:1), double-blind study to evaluate the efficacy and tolerability of axitinib in patients diagnosed with advanced G1-G2 neuroendocrine tumors (WHO 2010) of nonpancreatic origin that have presented documented disease progression in the 12 months prior to entering the study. In the first part of the study (Phase II), 105 patients were enrolled. The second part of the study is the expansion to Phase III, which is expected to include 148 additional patients. Patients will be randomized to receive Sandostatin LAR with axitinib or Sandostatin LAR with placebo until disease progression or unacceptable toxicity occurs. Randomization will be stratified by the time from diagnosis to enrollment in the study (more vs less than or equal to 12 months), the origin of the primary tumor (gastrointestinal tract vs non-gastrointestinal tract \[lung or other sites\]) and ki-67 (\< 5% vs \> 5%).
Status Flow
Change History
14 versions recorded-
May 4, 2026 — Present [daily]
Completed
Status: Unknown → Completed · Phase: PHASE2/PHASE3 → None
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Sep 2025 — May 2026 [monthly]
Unknown PHASE2/PHASE3
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Sep 2024 — Sep 2025 [monthly]
Unknown PHASE2/PHASE3
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Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2/PHASE3
Status: Unknown Status → Unknown · Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Mar 2023 — Jul 2024 [monthly]
Unknown Status PHASE2_PHASE3
Status: Active Not Recruiting → Unknown Status
▶ Show 9 earlier versions
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Mar 2021 — Mar 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2021 — Mar 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Nov 2019 — Apr 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Sep 2018 — Nov 2019 [monthly]
Recruiting PHASE2_PHASE3
Status: Active Not Recruiting → Recruiting
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Jul 2018 — Sep 2018 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2_PHASE3
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Sep 2017 — Jun 2018 [monthly]
Recruiting PHASE2_PHASE3
Status: Unknown Status → Recruiting · Phase: PHASE2 → PHASE2_PHASE3
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Jan 2017 — Sep 2017 [monthly]
Unknown Status PHASE2
First recorded
Nov 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
Assess whether therapy with axitinib, a potent angiogenic inhibitor of the tyrosine kinase receptors of VEGF bioavailable by oral administration, is capable of improving PFS in patients with advanced G1-G2 NETs of nonpancreatic origin with progressive disease documented in the 12 months prior to entering the study.
Contact Information
- Grupo Espanol de Tumores Neuroendocrinos
- Pfizer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , Barcelona, Spain , Bebington, United Kingdom , Burgos, Spain , Donostia / San Sebastian, Spain , Granada, Spain , L'Hospitalet de Llobregat, Spain , León, Spain , Madrid, Spain , Madrid, Spain and 16 more locations