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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01525550
First received: January 13, 2012
Last updated: November 6, 2014
Last verified: November 2014

January 13, 2012
November 6, 2014
June 2012
March 2016   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01525550 on ClinicalTrials.gov Archive Site
  • Time-to-tumor progression (TTP) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Baseline until death (up to 2 years) ] [ Designated as safety issue: No ]
  • Objective response (OR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Time-to-tumor response (TTR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of the use of Choi criteria [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of Chromogranin A response and soluble KIT concentrations [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Pharmacokinetic trough plasma concentrations of sunitinib and its active metabolite (SU12662) [ Time Frame: 4 timepoints up to 5 months ] [ Designated as safety issue: No ]
  • Patient reported outcomes is defined as health related quality of life using the self administered European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (EORTC QLQ C30) and EORTC QLQ GI.NET21 [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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.
 
Recruiting
80
March 2020
March 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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Australia,   Belgium,   China,   Czech Republic,   Estonia,   France,   Hungary,   India,   Italy,   Japan,   Norway,   Portugal,   Romania,   Slovakia,   South Africa,   Spain
 
NCT01525550
A6181202, 2011-004363-74
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP