Phase 3
N=256
Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas
Neuroendocrine Tumors · Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01744249 ↗Enrolled (actual)
256
Serious AEs
30.6%
Results posted
Apr 2026
Primary outcome: Primary: Efficacy of Axitinib in Terms of PFS (Investigator Assessment) — 17.2; 13.1 months — p=0.324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Axitinib (Drug); Sandostatin LAR (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Axitinib in Terms of PFS (Investigator Assessment) |
17.2; 13.1 | 0.324 |
| SECONDARY Objective Response Rate (ORR) (Investigator Assessment) |
2; 1; 20; 5; 87; 96 | 0.007 sig |
| SECONDARY Biochemical Response (5-OH-indoleacetic Acid and Chromogranin A) |
31; 27; 38; 45; 19; 16 | 0.407 |
| SECONDARY Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) |
121; 124; 4; 6; 48; 30 | — |
| SECONDARY Efficacy of Axitinib in Terms of PFS (Central Blinded Assessment) |
16.6; 9.9 | 0.017 sig |
| SECONDARY Objective Response Rate (ORR) (Central Blinded Assessment) |
2; 0; 13; 4; 98; 109 | 0.007 sig |
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.
Eligibility Criteria
Inclusion Criteria
- G1-G2 neuroendocrine tumor (WHO 2010) of histologically confirmed non-pancreatic origin, functioning and nonfunctioning
- Metastatic or locally advanced disease not amenable to treatment with curative intent
- Clinical and/or radiological disease progression documented in the 12 months prior to study entry.
- Patients should have at least one measurable lesion as defined by RECIST 1.1 criteria. Patients should not have undergone local or regional ablative procedures (embolization, cryoablation, radiofrequency ablation, or others) in the 6 months prior to entering the study, unless there are other locations of measurable disease or clear radiological progression after carrying out these procedures (in these cases, local and regional ablation procedures shall be permitted if they have been performed at least 1 month prior to enrollment in the study).
- Ki-67 450 ms for men or > 470 ms for women.
- Patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome-related disease.
- Prior history of cancer except those treated with curative intent for non-melanoma skin cancer in situ, breast or cervical cancer in situ, or those treated for any cancer with curative intent and no evidence of disease in the last 5 years prior to enrollment in the study.
- Dementia or significantly altered mental status that could prevent compression, or submission of informed consent and compliance with the requirements of this protocol.
- Any severe, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with participation in the study or with study drug administration, or that may interfere with the interpretation of results, and that could interfere with the patient's ability to take part in this study in the investigator's opinion.
- The patient's participation or intention to participate (in the 4 weeks prior to starting drug administration) in a study in which the patient will receive an investigational medicinal product.
- Subjects who are institutionalized by governmental or by judicial decision, or subjects who are dependent of the sponsor, the investigator or the trial site will be excluded from participation.
Data sourced from ClinicalTrials.gov (NCT01744249). 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.