NCT03387592 (SENECA) is a Phase 2 clinical trial of CPT-11 in Neuroendocrine Carcinoma, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS.

Who is sponsoring NCT03387592?

NCT03387592 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS.

What drugs are being tested in NCT03387592?

Interventions in NCT03387592: CPT-11, Calcio levofolinate, 5-Fluorouracil, Capecitabine, Temozolomide.

What condition does NCT03387592 study?

NCT03387592 studies Neuroendocrine Carcinoma.

Is NCT03387592 still recruiting?

NCT03387592 is currently terminated. Last updated 10 March 2025.

Last reviewed 2025-03-10 · How we verify

NCT03387592: SENECA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas

Terminated Phase 2 Last updated 10 March 2025

What this trial tests

Phase 2 trial testing CPT-11 in Neuroendocrine Carcinoma in 53 participants. Terminated before completion.

Timeline

6 March 2017

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	6 March 2017
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	23 locations across Italy

Drugs / interventions tested

CPT-11 — full drug profile →
Calcio levofolinate — full drug profile →
5-Fluorouracil
Capecitabine (capecitabine) — full drug profile →
Temozolomide (temozolomide) — full drug profile →

Conditions studied

Neuroendocrine Carcinoma — all drugs for Neuroendocrine Carcinoma →

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS — full company profile →

Who can join

18 and older, any sex, with Neuroendocrine Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are primary objectives, secondary objectives are Disease control rate (OS), Progression Free Survival (PFS), quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Biomarkers for Pancreatic Neuroendocrine Neoplasms (PanNENs) Management-An Updated Review.
Bocchini M, Nicolini F, Severi S, Bongiovanni A, et al · · 2020 · cited 36× · PMID 32537434 · DOI 10.3389/fonc.2020.00831
Expanding Therapeutic Opportunities for Extrapulmonary Neuroendocrine Carcinoma.
Frizziero M, Kilgour E, Simpson KL, Rothwell DG, et al · · 2022 · cited 30× · PMID 35091446 · DOI 10.1158/1078-0432.ccr-21-3058
Second-line treatment in patients with advanced extra-pulmonary poorly differentiated neuroendocrine carcinoma: a systematic review and meta-analysis.
McNamara MG, Frizziero M, Jacobs T, Lamarca A, et al · · 2020 · cited 30× · PMID 32426044 · DOI 10.1177/1758835920915299
Expert Consensus Practice Recommendations of the North American Neuroendocrine Tumor Society for the management of high grade gastroenteropancreatic and gynecologic neuroendocrine neoplasms.
Eads JR, Halfdanarson TR, Asmis T, Bellizzi AM, et al · · 2023 · cited 29× · PMID 37184955 · DOI 10.1530/erc-22-0206
Chemotherapy in NEN: still has a role?
Espinosa-Olarte P, La Salvia A, Riesco-Martinez MC, Anton-Pascual B, et al · · 2021 · cited 25× · PMID 33843007 · DOI 10.1007/s11154-021-09638-0
Systemic Treatment of Gastroenteropancreatic Neuroendocrine Carcinoma.
Mollazadegan K, Welin S, Crona J. · · 2021 · cited 21× · PMID 34110508 · DOI 10.1007/s11864-021-00866-9
Neuroendocrine Carcinomas with Atypical Proliferation Index and Clinical Behavior: A Systematic Review.
Feola T, Centello R, Sesti F, Puliani G, et al · · 2021 · cited 17× · PMID 33809007 · DOI 10.3390/cancers13061247
Potent molecular-targeted therapies for gastro-entero-pancreatic neuroendocrine carcinoma.
Ooki A, Osumi H, Fukuda K, Yamaguchi K. · · 2023 · cited 16× · PMID 37422534 · DOI 10.1007/s10555-023-10121-2

Verify or expand the search:

Other trials of CPT-11

Trials testing the same drug.

NCT03303495 — A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC · Phase 3 · unknown
NCT01040312 — An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors · completed

Other recruiting trials for Neuroendocrine Carcinoma

Currently open trials in the same condition.

NCT06937905 — Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic P · Phase 3 · recruiting
NCT06889493 — SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Dif · Phase 1 · recruiting
NCT06577987 — Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies · Phase 1 · recruiting
NCT06242119 — Clinical Application of the J-PET Scanner Prototype · recruiting
NCT04524208 — A Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3 · Phase 2 · active not recruiting

Other Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS trials

Trials by the same sponsor.

NCT06522919 — Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tip · Phase 2 · recruiting
NCT06390241 — Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer · Phase 1 · terminated
NCT05861336 — GEM+Nab-Paclitaxel Plus Losartan Followed by Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer · Phase 2 · withdrawn
NCT03454750 — Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) · Phase 2 · completed
NCT04826458 — Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03387592 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Last refreshed: 10 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03387592.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing