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

Sponsored by:	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 ]

Estimated Enrollment:	340
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2014
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

Show 54 Study Locations

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:	June 21, 2009
ClinicalTrials.gov Identifier:	NCT00428597 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pancreatic Islet Cell Tumors
Digestive System Neoplasms
Carcinoma, Islet Cell
Pancreatic Neoplasms
Endocrine System Diseases
Adenoma, Islet Cell
Angiogenesis Inhibitors
Carcinoma
Digestive System Diseases

Sunitinib
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Adenoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents
Growth Substances
Carcinoma, Islet Cell
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Adenoma, Islet Cell
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Digestive System Diseases
Sunitinib
Therapeutic Uses
Pancreatic Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Adenocarcinoma
Adenoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009