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NCT01215578: NET
A Multicenter Phase II Open Study Coupled With a Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.
Phase 2 trial testing Sutent in Neuroendocrine Tumors in 33 participants. Terminated before completion.
1 December 2013
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 October 2008 |
| Primary completion | 1 December 2013 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across France |
Drugs / interventions tested
- Sutent (sunitinib) — full drug profile →
Conditions studied
- Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →
- Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →
- Advanced Disease — all drugs for Advanced Disease →
- Sunitinib — all drugs for Sunitinib →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Neuroendocrine Tumors or Pancreatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Predictive molecular markers of response to sunitinib
Time frame: 1 year
to assess the correlation between the expression of biomarkers and CT scan response. Patients are considered as responders when objective response (Partial or complete response) is showed on CT scan.
Sponsor's own description
The purpose of this study is to identify predictive molecular markers of response to continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors. Hypothesis: * To distinguish molecular markers based on their expression at the initial biopsy, their detection by proteomic analysis and demonstrating that tumor or vascular cells are straightaway sensitive to sunitinib (markers sensitivity). * The presence of these markers at the initial biopsy predict the sensitivity to sunitinib(Positive predictive value of markers)
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cancer combination therapies by angiogenesis inhibitors; a comprehensive review.
Ansari MJ, Bokov D, Markov A, Jalil AT, et al · · 2022 · cited 117× · PMID 35392964 · DOI 10.1186/s12964-022-00838-y -
Randomised phase II trial of CAPTEM or FOLFIRI as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET/CT imaging and biological markers (SENECA trial): a study protocol.
Bongiovanni A, Liverani C, Pusceddu S, Leo S, et al · · 2020 · cited 14× · PMID 32690499 · DOI 10.1136/bmjopen-2019-034393
Verify or expand the search:
- PubMed search for NCT01215578
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01215578 (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 Assistance Publique - Hôpitaux de Paris
- Last refreshed: 29 April 2015
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/NCT01215578.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing