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A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Islet Cell, Carcinoma, Pancreas

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Trial Information

A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors


The study was terminated on 11 March 2009 because the independent Data Monitoring Committee
determined that the study had met its primary endpoint in demonstrating improvement in
progression-free survival. The decision to terminate the trial was not based on safety
concerns related to sunitinib administration.


Inclusion Criteria:



- Well-differentiated advanced/metastatic pancreatic islet cell tumor

- Tumor has shown progression within the past year.

Exclusion Criteria:

- Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or
investigational anticancer agent other than somatostatin analogues

- Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial
growth factor] angiogenic inhibitors.

- Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.

Outcome Time Frame:

From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death

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:

A6181111

NCT ID:

NCT00428597

Start Date:

June 2007

Completion Date:

April 2009

Related Keywords:

  • Carcinoma, Islet Cell
  • Carcinoma, Pancreas
  • Carcinoma
  • Adenoma, Islet Cell
  • Carcinoma, Islet Cell
  • Neuroendocrine Tumors

Name

Location

Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201