A phase III randomized, double-blind study of sunitinib (SU011248, sutent) versus placebo in patients with progressive advanced/ metastatic well-differentiated pancreatic islet cell tumors

Phase 3

Withdrawn

• Conditions: cancer; neuro endocine tumor; 10014713

• Registration Number: NL-OMON30440
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Proven diagnosis of well-differentiated pancreatic islet cell tumor.
- Locally-advanced or metatstic disease as having shown progression on a scan.

Exclusion Criteria

- Poorly-differentiated pancreatic neuro endocrine tumors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression-free Survival (PFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- overall survival (OS)<br /><br>- objective response (OR)<br /><br>- duration of response (DR)<br /><br>- time to tumor response (TTR)<br /><br>- safety and tolerability<br /><br>- patient reported outcomes (PRO)</p><br>