SNIPP study - A investigator initiated phase II study of sunitinib in patients with recurrent paraganglioma/pheochromocytoma

Phase 2

Completed

• Conditions: 10052547; 10014713; paraganglioma - tumors of neuroendocrine tissue

• Registration Number: NL-OMON37490
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

- metastatic or locally recurrent paraganglioma or pheochromocytoma not amenable to curative treatment modalities
- measurable disease
- ECOG performance status 0-2
- at least 28 days since proior radiation or major surgery
- able to take oral medicatio- able to stop prohibited selected CYP3A4 inhibitors

Exclusion Criteria

- prior therapy with antiangiogenic agents or multitargeted tyrosine kinase inhibitors
- known brain metastasis
- serious medical conditions or cardiac disease
- uncontrolled hypertension
- other concurrent anticancer treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the clinical benefit rate, defined as either a partial<br /><br>response, complete response or stable disease for at least 12 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>- biochemical response<br /><br>- overall survival<br /><br>- time to progression<br /><br>- overall response rate (partial response + complete response)<br /><br>- tumor symptom improvement</p><br>