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A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

NCT05050942 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2025-11-06

No results posted yet for this study

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.

Conditions

  • Gastro-enteropancreatic Neuroendocrine Tumor

Interventions

DRUG

CAM2029

CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection

DRUG

Octreotide LAR

Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

DRUG

Lanreotide ATG

Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

Sponsors & Collaborators

  • Camurus AB

    lead INDUSTRY

Principal Investigators

  • Simron Singh, MD, MPH · Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2026-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Romania
  • Spain

Study Locations

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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 NCT05050942 on ClinicalTrials.gov