A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
NCT01525550
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- 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.
- 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.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors | ||||||
| Official Title ICMJE | A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS | ||||||
| Brief Summary | The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors. | ||||||
| Detailed Description | This study is being conducted to meet regulatory post-marketing commitments. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Other | ||||||
| Condition ICMJE | Well-differentiated Pancreatic Neuroendocrine Tumor | ||||||
| Intervention ICMJE | Drug: sunitinib
Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days. | ||||||
| Study Arms ICMJE | Experimental: sunitinib
Intervention: Drug: sunitinib | ||||||
| Publications * | Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan 7. doi: 10.1007/s11523-020-00784-0. [Epub ahead of print] | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 106 | ||||||
| Original Estimated Enrollment ICMJE | 80 | ||||||
| Actual Study Completion Date ICMJE | July 26, 2018 | ||||||
| Actual Primary Completion Date | March 19, 2016 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Australia, Belgium, China, Czechia, France, Hungary, India, Italy, Japan, Norway, Romania, Slovakia, South Africa, Spain, United States | ||||||
| Removed Location Countries | Czech Republic, Estonia, Netherlands, Poland, Portugal | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01525550 | ||||||
| Other Study ID Numbers ICMJE | A6181202 2011-004363-74 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | July 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||