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

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Mayo Clinic Cancer Center (MCCC) - Phoenix
  Phoenix, Arizona, United States
• UCLA Ahmanson Biological Imaging Center
  Santa Monica, California, United States
• Rocky Mountain Cancer Centers - Denver - Midtown
  Denver, Colorado, United States
• Mayo Clinic Hospital - Florida
  Jacksonville, Florida, United States
• University of Kentucky (UK) - Markey Cancer Center
  Lexington, Kentucky, United States
• East Jefferson General Hospital
  Metairie, Louisiana, United States

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Simron Singh, MD, MPH — Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Octreotide SC Depot in Acromegaly: Real-World Safety and Effectiveness

  This study follows people with acromegaly who are using octreotide subcutaneous depot to see how it works and how safe it is over up to two years in everyday clinical practice.

  Recruiting at 4 sites Camurus AB · Aachen and 6 other locations · NCT07583563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.