Phase 4
N=106
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Well-differentiated Pancreatic Neuroendocrine Tumor
Bottom Line
View on ClinicalTrials.gov: NCT01525550 ↗Enrolled (actual)
106
Serious AEs
27.4%
Results posted
May 2017
Primary outcome: Primary: Progression-Free Survival (PFS): Investigator Assessment — 13.2; 13.0 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS): Investigator Assessment |
13.2; 13.0 | — |
| SECONDARY Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment |
11.1; 9.5 | — |
| SECONDARY Time to Tumor Progression (TTP): Investigator Assessment |
14.8; 14.5 | — |
| SECONDARY Overall Survival (OS) |
NA; 37.9 | — |
| SECONDARY Percentage of Participants With Objective Response (OR): Investigator Assessment |
21.3; 28.9 | — |
| SECONDARY Duration of Response (DOR): Investigator Assessment |
19.1; 14.7 | — |
| SECONDARY Time to Tumor Response (TTR): Investigator Assessment |
3.8; 3.8 | — |
| SECONDARY Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment |
52.5; 55.6 | — |
| SECONDARY Duration of Response (DOR): Independent Radiological Review (IRR) Assessment |
NA; 19.2 | — |
| SECONDARY Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment |
1.0; 1.0 | — |
| SECONDARY Percentage of Participants With Chromogranin A (CgA) Response |
16.4; 11.1 | — |
| SECONDARY Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) |
71.31; 66.09; 69.94; 65.45; 70.30; 60.83 | — |
| SECONDARY Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21) |
9.47; 15.66; 9.94; 14.91; 14.75; 11.67 | — |
| SECONDARY Plasma Concentration of Soluble Protein Biomarker (sKIT) |
58218.8; 62267.7; 51614.2; 48946.4; 37705.1; 40334.8 | — |
| SECONDARY Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662 |
52.78; 41.93; 42.68; 38.38; 41.79; 38.49 | — |
| SECONDARY Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662 |
52.66; 43.38; 42.89; 39.52; 44.99; 38.56 | — |
| SECONDARY Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662 |
— | — |
| SECONDARY Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662 |
— | — |
| SECONDARY Half Maximal Effective Concentration (EC50) of Sunitinib |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
59; 45; 17; 12 | — |
| SECONDARY Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
57; 44; 9; 3 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) According to Severity |
4; 5; 9; 9; 38; 23 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
30; 22 | — |
| SECONDARY Number of Participants With Change From Baseline in Vital Signs Abnormalities |
30; 22 | — |
| SECONDARY Number of Participants With Increase From Baseline in Corrected QT Interval (QTc) |
0; 0 | — |
| SECONDARY Number of Participants With Change From Baseline in Physical Examinations Findings |
23; 19 | — |
| SECONDARY Number of Participants With Change From Baseline in Body Weight |
27; 9; 18; 15 | — |
| SECONDARY Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS) |
37; 25; 15; 14; 9; 6 | — |
Summary
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization [WHO 2000] classification).
- Disease progression within 12 months prior to study enrollment.
- Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
Exclusion Criteria
- Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification).
- Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
Data sourced from ClinicalTrials.gov (NCT01525550). 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.