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

Overview

About this study

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 Gastroenteropancreatic-Neuroendocrine Tumors (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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/22/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thorvardur Halfdanarson, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Starr, D.O.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Bassam Sonbol, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions