Treatment With SU11248 in Patients With Neuroendocrine Tumors
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00056693
First received: March 20, 2003
Last updated: July 18, 2008
Last verified: July 2008
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Purpose
To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroendocrine Tumors |
Drug: Sunitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Radiographic objective disease response [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess safety (adverse events and lab abnormalities) [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
- To assess patient-reported outcomes and treatment-related symptoms [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
- To assess pharmacokinetics and biomarkers [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
- To assess overall survival at 1 year [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
- To assess other measures of antitumor efficacy including TTP and survival [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | April 2003 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: Sutent, SU011248
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056693
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033-0800 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115-1705 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Pinckneyville, Illinois, United States, 62274 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St Louis, Missouri, United States, 63110 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00056693 History of Changes |
| Other Study ID Numbers: | RTKC-0511-015 |
| Study First Received: | March 20, 2003 |
| Last Updated: | July 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Neuroendocrine tumor, advanced disease, sunitinib, Phase 2 |
Additional relevant MeSH terms:
|
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013