Treatment With SU11248 in Patients With Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056693
• Other study ID #: RTKC-0511-015
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2003
• Last updated: July 18, 2008
• Start date: April 2003
• Est. completion date: September 2006

Study information

• Verified date: July 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.

• Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).

• ECOG performance status 0 or 1

Exclusion Criteria:

• Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.

• Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Pinckneyville	Illinois
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	St Louis	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic objective disease response		From screening until disease progression or discontinuation of study	No
Secondary	To assess safety (adverse events and lab abnormalities)		From screening until patient death or discontinuation of study	No
Secondary	To assess patient-reported outcomes and treatment-related symptoms		From screening until patient death or discontinuation of study	No
Secondary	To assess pharmacokinetics and biomarkers		From screening until patient death or discontinuation of study	No
Secondary	To assess overall survival at 1 year		From screening until patient death or discontinuation of study	No
Secondary	To assess other measures of antitumor efficacy including TTP and survival		From screening until patient death or discontinuation of study	No

External Links

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