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Treatment With SU11248 in Patients With Neuroendocrine Tumors

Primary Purpose

Neuroendocrine Tumors

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Neuroendocrine tumor, advanced disease, sunitinib, Phase 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Radiographic objective disease response

Secondary Outcome Measures

To assess safety (adverse events and lab abnormalities)

To assess patient-reported outcomes and treatment-related symptoms

To assess pharmacokinetics and biomarkers

To assess overall survival at 1 year

To assess other measures of antitumor efficacy including TTP and survival

Full Information

NCT ID

NCT00056693

First Posted

March 20, 2003

Last Updated

July 18, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00056693

Brief Title

Treatment With SU11248 in Patients With Neuroendocrine Tumors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors

Keywords

Neuroendocrine tumor, advanced disease, sunitinib, Phase 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent, SU011248

Intervention Description

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

Primary Outcome Measure Information:

Title

Radiographic objective disease response

Time Frame

From screening until disease progression or discontinuation of study

Secondary Outcome Measure Information:

Title

To assess safety (adverse events and lab abnormalities)

Time Frame