Patients With High-grade Pancreatic Neuroendocrine Tumors

Study Purpose

- Pancreatic neuroendocrine tumor (pNET) is a rare form of cancer.

Treatment options such as hormonal therapy (octreotide) and targeted therapy (everolimus and sunitinib) may be considered for grade 1 or 2 pNETs; however, cytotoxic chemotherapy is essential in cases with grade 3 pNETs or pNECs.

- Cisplatin/etoposide remains the treatment of choice for high-grade pNET/pNEC.

Other irinotecan-based therapies, such as FOLFIRI (cisplatin/irinotecan), FOLFOX, and temozolomide ± capecitabine, have been employed; however, a standard of care remains to be established.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Clinical diagnosis of Pancreatic neuroendocrine tumor or neuroendocrine carcinoma.

- Documented failure of prior standard anti-cancer treatment.

- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³ - Platelet count ≥ 100,000 cells/mm³ - Ability to understand study content, willingness to comply with study procedures, and commitment to complete the study.

Exclusion Criteria:

- Currently receiving treatment for other cancers (except those who completed treatment and have been disease-free for at least 2 years prior to enrollment) - Pregnant or breastfeeding women.

- Deemed unsuitable for participation by the investigator due to clinical or medical reasons

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07121478
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Center, Korea
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sang Myung Woo(Principal), MD
Principal Investigator Affiliation	National Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	South Korea
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumor of Pancreas, Pancreatic Neuroendocrine Tumors

Additional Details

- Lurbinectedin, a selective inhibitor of oncogenic transcription, recently received accelerated FDA approval for lung cancer (small cell type) after demonstrating efficacy in an open-label, phase II basket study (ORR 35%, mOS 9.3 months, mPFS 3.5 months).

- A previous study that involved patients with grade 2 or higher NET/NEC who had undergone treatment with lurbinectedin revealed that the ORR, mOS, and mPFS of the six patients with pNET was 6.5%, 7.4 months, and 1.4 months, respectively.

Arms & Interventions

Arms

Experimental: single arm

Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.

Interventions

Drug: - Lurbinectedin 4 MG Injection [Zepzelca]

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National Cancer Center, Goyang-si 1842485, Gyeonggi-do 1841610, South Korea

Status

Address

National Cancer Center

Goyang-si 1842485, Gyeonggi-do 1841610, 10408

Clinical Trial Finder