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

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NCT01525550

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Univeristy of California
Orange, California, 92868 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Well-differentiated Pancreatic Neuroendocrine Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01525550
Pfizer
Completed
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

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Pfizer Clinical Trials Contact Center

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[email protected]

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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 (Registered)) In Patients With Progressive Advanced Metastatic Well-differentiated Unresectable Pancreatic Neuroendocrine Tumors
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.
This study is being conducted to meet regulatory post-marketing commitments.
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Other
Well-differentiated Pancreatic Neuroendocrine Tumor
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.
Experimental: sunitinib
Intervention: Drug: sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
June 29, 2018
March 19, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   China,   Czech Republic,   France,   Hungary,   India,   Italy,   Japan,   Norway,   Romania,   Slovakia,   South Africa,   Spain,   United States
Estonia,   Netherlands,   Poland,   Portugal
 
NCT01525550
A6181202
2011-004363-74 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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