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

Tracking Information

First Received Date ^ICMJE

January 29, 2007

Last Updated Date

July 14, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Progression free survival

Change History

Complete list of historical versions of study NCT00428597 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Overall survival Tumor response Duration of response Time to response Safety and tolerability Patient-reported outcomes

Descriptive Information

Brief Title ^ICMJE

A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Islet Cell

Intervention ^ICMJE

Drug: sunitinib malate
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

171

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00428597

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A6181111

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2009

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