Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Official Title

A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET

Keywords

Gastro-enteropancreatic Neuroendocrine Tumor, CAM2029, GEP-NET, Octreotide, SORENTO, Neuroendocrine Tumors, Lanreotide, Octreotide LAR, Lanreotide ATG

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female patient ≥18 years old
  • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
  • At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
  • ECOG performance status of 0 to 2

You CAN'T join if...

  • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
  • Known central nervous system metastases
  • Consecutive treatment with long-acting SSAs for more than 6 months before randomization
  • Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
  • Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
  • Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
  • Previously received radioligand therapy (PRRT) at any time

Locations

  • UCLA Ahmanson Biological Imaging Center
    Santa Monica California 90404 United States
  • Mayo Clinic Cancer Center (MCCC) - Phoenix
    Phoenix Arizona 85054 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Camurus AB
ID
NCT05050942
Phase
Phase 3 Neuroendocrine Tumor Research Study
Study Type
Interventional
Participants
About 332 people participating
Last Updated