Treatment With SU11248 in Patients With Neuroendocrine Tumors

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00056693

Enrollment

107

Registered

2003-03-24

Start date

2003-04-30

Completion date

2006-09-30

Last updated

2008-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine tumor, advanced disease, sunitinib, Phase 2

Brief summary

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

Interventions

DRUGSunitinib

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Radiographic objective disease response	From screening until disease progression or discontinuation of study

Secondary

Measure	Time frame
To assess safety (adverse events and lab abnormalities)	From screening until patient death or discontinuation of study
To assess patient-reported outcomes and treatment-related symptoms	From screening until patient death or discontinuation of study
To assess pharmacokinetics and biomarkers	From screening until patient death or discontinuation of study
To assess overall survival at 1 year	From screening until patient death or discontinuation of study
To assess other measures of antitumor efficacy including TTP and survival	From screening until patient death or discontinuation of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026