Phase 2
N=12
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01121562 ↗Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Aug 2012
Primary outcome: Primary: Clinical Benefit Response Rate (CBR) — 75.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sunitinib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Response Rate (CBR) |
75.0 | — |
| SECONDARY Objective Response Rate (ORR) |
50.0 | — |
| SECONDARY Tumor Shrinkage |
-20.0; -14.4; -18.0; -26.0; -28.5; -31.8 | — |
| SECONDARY Progression-free Survival (PFS) |
16.8 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). |
53.9; 41.7; 49.9; 53.5; 23.7; 21.2 | — |
Summary
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
Eligibility Criteria
Inclusion Criteria
- Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)
Exclusion Criteria
- Patients with poorly differentiated neuroendocrine cancer are not eligible
Data sourced from ClinicalTrials.gov (NCT01121562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.