A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS(A6181202)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223150

Enrollment

Registered

2016-03-23

Start date

2013-11-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced well-differentiated pancreatic neuroendocrine tumor

Interventions

investigational material(s) Generic name etc : SU011248 L-malate salt INN of investigational material : Sunitinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization [WHO 2000] classification). * Disease progression within 12 months prior to study enrollment. * Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.

Exclusion criteria

Exclusion criteria: * Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification). * Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.

Design outcomes

Primary

Measure	Time frame
efficacy Progression-Free Survival (PFS): Investigator Assessment	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics other * Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment * Overall Survival (OS) * Percentage of Participants With Objective Response (OR) * Duration of Response (DOR) * Time to Tumor Response (TTR) * Percentage of Participants With Chromogranin A (CgA) Response and Plasma Concentration of Soluble Protein Biomarker (sKIT) * Plasma Concentration of Sunitinib and Its Metabolite SU012662 * Quality of Life Measured by EORTC QLQ-C30 and EORTC QLQ-GI NET 21	—

Measure

Time frame

safety efficacy pharmacokinetics other * Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment * Overall Survival (OS) * Percentage of Participants With Objective Response (OR) * Duration of Response (DOR) * Time to Tumor Response (TTR) * Percentage of Participants With Chromogranin A (CgA) Response and Plasma Concentration of Soluble Protein Biomarker (sKIT) * Plasma Concentration of Sunitinib and Its Metabolite SU012662 * Quality of Life Measured by EORTC QLQ-C30 and EORTC QLQ-GI NET 21

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Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026