A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00428597

Purpose

This study will randomize patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who are randomized to sunitinib will receive 37.5 mg of sunitinib daily, those randomized to placebo will receive a tablet that looks similar but has no active drug. Neither the patient or the doctor will know whether the patient is receiving sunitinib or placebo. Patients will be followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

Condition	Intervention	Phase
Carcinoma, Islet Cell	Drug: sunitinib malate Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib Malic acid

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression free survival [ Time Frame: duration of study until PD, or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to response [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Patient-reported outcomes [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Tumor response [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Enrollment:	171
Study Start Date:	March 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: sunitinib malate sunitinib malate oral starting dose 37.5 mg daily (continuous dosing). Dose may be decreased to 25 mg daily in case of adverse events. It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment. Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination.
B: Placebo Comparator	Drug: Placebo -Placebo to match sunitinib - taken daily (oral) on the same schedule as active agent below.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428597

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Locations

United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Iowa
Pfizer Investigational Site
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01605
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Missouri
Pfizer Investigational Site
Creve Coeur, Missouri, United States, 63141
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110-1094
Pfizer Investigational Site
St. Peters, Missouri, United States, 63376
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Austin, Texas, United States, 78745
Pfizer Investigational Site
Georgetown, Texas, United States, 78626
Pfizer Investigational Site
Austin, Texas, United States, 78759
Pfizer Investigational Site
Austin, Texas, United States, 78758
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23510
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia, 6000
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1200
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3A 1A1
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Pfizer Investigational Site
Montreal, Quebec, Canada, H2X 3J4
France
Pfizer Investigational Site
Clichy Cedex, France, 92118
Pfizer Investigational Site
MARSEILLE, France, 13385
Pfizer Investigational Site
LYON, France, 69003
Pfizer Investigational Site
BORDEAUX, France, 33000
Pfizer Investigational Site
Rennes Cedex, France, 35062
France, BE1 05677
Pfizer Investigational Site
Paris, BE1 05677, France, 75571
France, Cedex
Pfizer Investigational Site
Paris, Cedex, France, 75679
Germany
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Bad Berka, Germany, 99437
Pfizer Investigational Site
Luebeck, Germany, 23538
Pfizer Investigational Site
Ulm, Germany, 89081
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Marburg, Germany, 35043
Italy
Pfizer Investigational Site
Rozzano (MI), Italy, 20089
Pfizer Investigational Site
Cremona, Italy, 26100
Pfizer Investigational Site
Milano, Italy, 20141
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Spain
Pfizer Investigational Site
BARCELONA, Spain, 08035
Pfizer Investigational Site
MADRID, Spain, 28041
Pfizer Investigational Site
MADRID, Spain, 28007
Pfizer Investigational Site
BARCELONA, Spain, 08025
Pfizer Investigational Site
MADRID, Spain, 28046
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Taiwan, Taoyuan
Pfizer Investigational Site
Kwei-Shan, Taoyuan, Taiwan, 333
United Kingdom
Pfizer Investigational Site
Liverpool, United Kingdom, L69 3GA
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181111
Study First Received:	January 29, 2007
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00428597 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms by Site
Sunitinib
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances

Carcinoma, Islet Cell
Endocrine System Diseases
Adenoma, Islet Cell
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Pancreatic Diseases
Adenocarcinoma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009