A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Running, not enrolling · Phase 3
Conditions studied: Gastro-enteropancreatic Neuroendocrine Tumor
In brief
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.
Key facts
- Study ID
- NCT05050942
- Run by
- Camurus AB
- People needed
- 332
- Starts
- 2021-10-22
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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
Where it is running
- 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
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Texas Oncology - Austin — Austin, Texas, United States
- Texas Oncology - Dallas — Dallas, Texas, United States
- The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States
- Texas Oncology - McAllen — McAllen, Texas, United States
- Texas Oncology - San Antonio Northeast — San Antonio, Texas, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- GenesisCare - North Shore — Alexandria, Australia
- Fiona Stanley Hospital — Murdoch, Australia
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
- Hôpital Erasme — Brussels, Belgium
- Antwerp University Hospital — Edegem, Belgium
- Algemeen Ziekenhuis Maria Middelares — Ghent, Belgium
- AZ Nikolaas — Sint-Niklaas, Belgium
- London Health Sciences Centre — London, Canada
- Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital — Montreal, Canada
- Jewish General Hospital — Montreal, Canada
- Mayo Clinic Cancer Center (MCCC) - Phoenix — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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