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
1 other identifier
interventional
107
1 country
11
Brief Summary
To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2003
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2003
CompletedFirst Posted
Study publicly available on registry
March 24, 2003
CompletedStudy Start
First participant enrolled
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJuly 21, 2008
July 1, 2008
3.4 years
March 20, 2003
July 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic objective disease response
From screening until disease progression or discontinuation of study
Secondary Outcomes (5)
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
Study Arms (1)
A
EXPERIMENTALInterventions
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (11)
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
Pfizer Investigational Site
Los Angeles, California, 90033-0800, United States
Pfizer Investigational Site
Los Angeles, California, 90033, United States
Pfizer Investigational Site
San Francisco, California, 94115-1705, United States
Pfizer Investigational Site
Pinckneyville, Illinois, 62274, United States
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Pfizer Investigational Site
Boston, Massachusetts, 02115, United States
Pfizer Investigational Site
Boston, Massachusetts, 02215, United States
Pfizer Investigational Site
St Louis, Missouri, 63110, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111, United States
Related Publications (2)
Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21.
PMID: 29161241DERIVEDZurita AJ, Khajavi M, Wu HK, Tye L, Huang X, Kulke MH, Lenz HJ, Meropol NJ, Carley W, DePrimo SE, Lin E, Wang X, Harmon CS, Heymach JV. Circulating cytokines and monocyte subpopulations as biomarkers of outcome and biological activity in sunitinib-treated patients with advanced neuroendocrine tumours. Br J Cancer. 2015 Mar 31;112(7):1199-205. doi: 10.1038/bjc.2015.73.
PMID: 25756398DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2003
First Posted
March 24, 2003
Study Start
April 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
July 21, 2008
Record last verified: 2008-07