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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Thorvardur Halfdanarson, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Jason Starr, D.O.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Mohamad Bassam Sonbol, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20531304

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