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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Well-differentiated Pancreatic Neuroendocrine Tumor

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Trial Information

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


This study is being conducted to meet regulatory post-marketing commitments.


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:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

Baseline up to 2 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181202

NCT ID:

NCT01525550

Start Date:

June 2012

Completion Date:

March 2020

Related Keywords:

  • Well-differentiated Pancreatic Neuroendocrine Tumor
  • neuroendocrine tumors
  • adenoma islet cells
  • carcinoma islet cells
  • pancreatic neoplasms
  • angiogenesis inhibitors
  • sunitinib
  • neoplasms
  • carcinoma
  • adenoma
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell

Name

Location

Henry Ford HospitalDetroit, Michigan  48202
Robert Packer HospitalSayre, Pennsylvania  18840
Henry Ford Medical CenterDearborn, Michigan  48126
Henry Ford Medical Center-FairlaneDearborn, Michigan  48126
Guthrie Clinic, Ltd.Sayre, Pennsylvania  18840
Univeristy of CaliforniaOrange, CA, California  Orange, CA
Henry Ford Medical Center-JosephineBrownstown, Michigan  48183