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Treatment With SU11248 in Patients With Neuroendocrine Tumors

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00056693
Collaborator
(none)
107
Enrollment
12
Locations
1
Arm
41
Duration (Months)
8.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
Other Names:
  • Sutent, SU011248

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Radiographic objective disease response [From screening until disease progression or discontinuation of study]

    Secondary Outcome Measures

    1. To assess safety (adverse events and lab abnormalities) [From screening until patient death or discontinuation of study]

    2. To assess patient-reported outcomes and treatment-related symptoms [From screening until patient death or discontinuation of study]

    3. To assess pharmacokinetics and biomarkers [From screening until patient death or discontinuation of study]

    4. To assess overall survival at 1 year [From screening until patient death or discontinuation of study]

    5. To assess other measures of antitumor efficacy including TTP and survival [From screening until patient death or discontinuation of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Birmingham Alabama United States 35233
    2 Pfizer Investigational Site Birmingham Alabama United States 35294
    3 Pfizer Investigational Site Los Angeles California United States 90033-0800
    4 Pfizer Investigational Site Los Angeles California United States 90033
    5 Pfizer Investigational Site San Francisco California United States 94115-1705
    6 Pfizer Investigational Site Pinckneyville Illinois United States 62274
    7 Pfizer Investigational Site Boston Massachusetts United States 02114
    8 Pfizer Investigational Site Boston Massachusetts United States 02115
    9 Pfizer Investigational Site Boston Massachusetts United States 02215
    10 Pfizer Investigational Site St Louis Missouri United States 63110
    11 Pfizer Investigational Site St. Louis Missouri United States 63110
    12 Pfizer Investigational Site Philadelphia Pennsylvania United States 19111

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00056693
    Other Study ID Numbers:
    • RTKC-0511-015
    First Posted:
    Mar 24, 2003
    Last Update Posted:
    Jul 21, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Neuroendocrine tumor, advanced disease, sunitinib, Phase 2
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Sunitinib

    Study Results

    No Results Posted as of Jul 21, 2008