Phase II Study of cisplatin and everolimus in patients with metastatic or unresectable neuroendocrine carcinomas (NEC) of extrapulmonary origi

• Conditions: patients with metastatic or unresectable neuroendocrine carcinomas (NEC) of extrapulmonary origin

• Registration Number: NL-OMON24870
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

1.Pathologically confirmed unresectable locally advanced NEC where no curative (chemoradiation) treatment options are available, and/or metastatic NECs of extrapulmonary origin as first line therapy NEC of extrapulmonary origin (WHO 2010 classification; Ki67 >20 %) including merkel cell carcinoma.

2.Measurable disease according to RECIST 1.1, on CT-scan or MRI

Exclusion Criteria

1.Previous chemotherapy for metastatic or unresectable NEC of extrapulmonary origin. (prior peri-operative chemotherapy or chemoradiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and enrolment into the study).

2.Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus, everolimus)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint of this study will be Disease Control Rate (DCR), defined as the sum of Overall Response Rate (ORR) consisting of Complete (CR), Partial Response Rate (PR) and stable disease (SD), all according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will be Time to relapse; Progression-free survival (PFS); Disease-free survival (DFS); Overall survival (OS); Effect on the markers chromogranin A (CgA) and neuron-specific enolase (NSE); Safety of everolimus in combination with cisplatin.