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

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

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Sunitinib Sunitinib malate Malic acid

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	340
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (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.

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

Contacts


Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 69 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181111
First Received:	January 29, 2007
Last Updated:	October 11, 2008
ClinicalTrials.gov Identifier:	NCT00428597
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Neoplasms

Carcinoma, Islet Cell

Pancreatic Neoplasms

Endocrine System Diseases

Adenoma, Islet Cell

Carcinoma

Digestive System Diseases

Sunitinib

Gastrointestinal Neoplasms

Pancreatic Diseases

Endocrinopathy

Adenocarcinoma

Pancreatic islet cell tumors

Adenoma

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

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