Treatment With SU11248 in Patients With Neuroendocrine Tumors

NCT00056693

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuroendocrine Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Neuroendocrine TumorsTreatment With SU11248 in Patients With Neuroendocrine Tumors
NCT00056693
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Los Angeles, California
  4. Los Angeles, California
  5. San Francisco, California
  6. Pinckneyville, Illinois
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Boston, Massachusetts
  10. St Louis, Missouri
  11. St. Louis, Missouri
  12. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Treatment With SU11248 in Patients With Neuroendocrine Tumors
Official Title  ICMJE A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
Brief Summary To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
Other Name: Sutent, SU011248
Study Arms  ICMJE Experimental: A
Intervention: Drug: Sunitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2008)
107
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00056693
Other Study ID Numbers  ICMJE RTKC-0511-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP