Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors
NCT01215578 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2015-04-30
Summary
The purpose of this study is to identify predictive molecular markers of response to continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.
Hypothesis:
* To distinguish molecular markers based on their expression at the initial biopsy, their detection by proteomic analysis and demonstrating that tumor or vascular cells are straightaway sensitive to sunitinib (markers sensitivity).
* The presence of these markers at the initial biopsy predict the sensitivity to sunitinib(Positive predictive value of markers)
Conditions
- Neuroendocrine Tumors
- Pancreatic Neoplasms
- Advanced Disease
- Sunitinib
Interventions
- DRUG
-
Sutent
sunitinib 37.5 mg/day (per os) for 6 months
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Eric Raymond, Professor · Assistance Publique - Hôpitaux de Paris
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2013-12-31
- Completion
- 2014-12-31
Countries
- France
Study Locations
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