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OpenTrials
Completed

NCT Number: NCT00056693

Treatment With SU11248 in Patients With Neuroendocrine Tumors

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

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sunitinib

Drug

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

Other names: Sutent, SU011248

Primary outcomes

  1. Radiographic objective disease response

    Time frame: From screening until disease progression or discontinuation of study

Secondary outcomes

  1. To assess safety (adverse events and lab abnormalities)

    Time frame: From screening until patient death or discontinuation of study

  2. To assess patient-reported outcomes and treatment-related symptoms

    Time frame: From screening until patient death or discontinuation of study

  3. To assess pharmacokinetics and biomarkers

    Time frame: From screening until patient death or discontinuation of study

  4. To assess overall survival at 1 year

    Time frame: From screening until patient death or discontinuation of study

  5. To assess other measures of antitumor efficacy including TTP and survival

    Time frame: From screening until patient death or discontinuation of study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Mar 24, 2003
Registry last updated
Jul 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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