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Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas

NCT01744249 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2026-04-28

Study results available
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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.

Conditions

Interventions

DRUG

Axitinib

Orally, 5mg, twice daily, until progression or until unacceptable toxicity, with or without food intake.

DRUG

Sandostatin LAR

Intramuscular, 30mg, single injection every 28 days, until disease progression or unacceptable toxicity

DRUG

Placebo

orally, twice daily, until disease progression or unacceptable toxicity, with or without food intake.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Grupo Espanol de Tumores Neuroendocrinos

    lead OTHER

Principal Investigators

  • Rocio Garcia Carbonero, MD · Hospital 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744249 on ClinicalTrials.gov