NCT04194125 is a Phase 2 clinical trial of 177Lu-DOTATOC in Neuroendocrine Tumors, sponsored by University of Warmia and Mazury.

Who is sponsoring NCT04194125?

NCT04194125 is sponsored by University of Warmia and Mazury.

What drugs are being tested in NCT04194125?

Interventions in NCT04194125: 177Lu-DOTATOC.

What condition does NCT04194125 study?

NCT04194125 studies Neuroendocrine Tumors.

Is NCT04194125 still recruiting?

NCT04194125 is currently status unknown. Last updated 4 November 2020.

Last reviewed 2020-11-04 · How we verify

NCT04194125

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

Personalized CAPTEM Radiopeptide Therapy of Advanced, Non-resectable Neuroendocrine Cancer

Status unknown Phase 2 Last updated 4 November 2020

What this trial tests

Phase 2 trial testing 177Lu-DOTATOC in Neuroendocrine Tumors in 25 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
30 June 2021

31 January 2022

Quick facts

Lead sponsor	University of Warmia and Mazury
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 February 2019
Primary completion	30 June 2021
Estimated completion	31 January 2022
Sites	1 location across Poland

Drugs / interventions tested

177Lu-DOTATOC — full drug profile →

Conditions studied

Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →

Sponsor

University of Warmia and Mazury

Who can join

Adults 18 to 85, any sex, with Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a non-randomized, phase II, open label study. The purpose of this study is to estimate Progression Free Survival (PFS) after treatment with Peptide Receptor Radionuclide Therapy (PRRT) 177Lu-DOTATOC standard dose (up to 4x7,4GBq 177Lu DOTATOC) in combination with capecitabine (CAP) and temozolomide (TEM) - CAPTEM. Patients with advanced, non-resectable and/or progressive gastro-entero-pancreatic neuroendocrine tumors, GEP-NET, (G1, G2), in selected cases with high proliferation index (Ki-67\> 20%, usually below 55%), NETG3, with overexpression of somatostatin receptor (SSTR positive) will be enrolled in the study.

Publications & conference data

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

Peptide receptor radionuclide therapy combinations for neuroendocrine tumours in ongoing clinical trials: status 2023.
di Santo G, Santo G, Sviridenko A, Virgolini I. · · 2024 · cited 24× · PMID 38250038 · DOI 10.7150/thno.91268
Targeted Cancer Therapy: What's New in the Field of Neuroendocrine Neoplasms?
La Salvia A, Espinosa-Olarte P, Riesco-Martinez MDC, Anton-Pascual B, et al · · 2021 · cited 19× · PMID 33916707 · DOI 10.3390/cancers13071701
Somatostatin receptor radionuclide therapy in neuroendocrine tumors.
Haider M, Das S, Al-Toubah T, Pelle E, et al · · 2021 · cited 14× · PMID 33608483 · DOI 10.1530/erc-20-0360
Therapy Resistant Gastroenteropancreatic Neuroendocrine Tumors.
McClellan K, Chen EY, Kardosh A, Lopez CD, et al · · 2022 · cited 12× · PMID 36230691 · DOI 10.3390/cancers14194769
Efficacy and safety of temozolomide-based regimens in advanced pancreatic neuroendocrine tumors: a systematic review and meta-analysis.
Taherifard E, Bakhtiar M, Mahnoor M, Ahmed R, et al · · 2024 · cited 6× · PMID 38347461 · DOI 10.1186/s12885-024-11926-2
Targeted radionuclide therapy in endocrine-related cancers: advances in the last decade.
Al-Toubah T, Strosberg J, Hallanger-Johnson J, El-Haddad G. · · 2023 · cited 3× · PMID 38053729 · DOI 10.3389/fendo.2023.1187870

Verify or expand the search:

Other trials of 177Lu-DOTATOC

Trials testing the same drug.

NCT04915144 — 177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs · Phase 2 · withdrawn
NCT05387603 — Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. · Phase 3 · recruiting
NCT04276597 — Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus · Phase 2 · withdrawn

Other recruiting trials for Neuroendocrine Tumors

Currently open trials in the same condition.

NCT07404176 — Study to Assess the Safety and Effectiveness of Novel Radiopharmaceutical Terbium-161 DOTATATE in Metastatic Neuroendocr · Phase 2 · recruiting
NCT07314164 — Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment · recruiting
NCT07272512 — Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms · Phase 4 · recruiting
NCT06735560 — Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, ICC or NEN · NA · recruiting
NCT06889493 — SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Dif · Phase 1 · recruiting

Other University of Warmia and Mazury trials

Trials by the same sponsor.

NCT04331912 — PFS and OS of Patients With Advanced Neuroendocrine Cancer (NEN) After Systemic Treatment · unknown
NCT04000126 — Pupillometry - Future of Objective Pain Reaction Measurement While Unconscious · NA · completed
NCT04241887 — Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors · NA · completed
NCT03771027 — Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain. · NA · completed
NCT03559608 — Arterial Hypertension in Men in the Warmia and Masuria Region · unknown

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 NCT04194125 (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 University of Warmia and Mazury
Last refreshed: 4 November 2020

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/NCT04194125.

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