A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
Overview
- Phase
- Phase 2
- Intervention
- Sunitinib
- Conditions
- Pancreatic Neuroendocrine Tumors
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 4
- Primary Endpoint
- Clinical Benefit Response Rate (CBR)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
Investigators
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
Arms & Interventions
Sunitinib arm
Intervention: Sunitinib
Outcomes
Primary Outcomes
Clinical Benefit Response Rate (CBR)
Time Frame: Up to 799 days of treatment
CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to 799 days of treatment)
- Tumor Shrinkage(Up to 799 days of treatment)
- Progression-free Survival (PFS)(Up to 799 days of treatment)
- Overall Survival (OS)(Up to 3 years from the last subject registration to the study)
- Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).(Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1)