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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Tumors

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Radiographic objective disease response

Outcome Time Frame:

From screening until disease progression or discontinuation of study

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

RTKC-0511-015

NCT ID:

NCT00056693

Start Date:

April 2003

Completion Date:

September 2006

Related Keywords:

  • Neuroendocrine Tumors
  • Neuroendocrine tumor, advanced disease, sunitinib, Phase 2
  • Neuroendocrine Tumors

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535