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ENROLLING BY INVITATION
NCT05385861
PHASE1/PHASE2

Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET

Sponsor: National Health Research Institutes, Taiwan

View on ClinicalTrials.gov

Summary

The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy.

Official title: A Phase I/II Study of Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinoma

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2025-08-14

Completion Date

2025-12-31

Last Updated

2025-08-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

nanoliposomal irinotecan plus carboplatin

Dose in phase 1 cohort: Dose level 1= nanoliposomal irinotecan 100 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level 0= nanoliposomal irinotecan 80 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level -1= nanoliposomal irinotecan 60 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Carboplatin dose (mg) is calculated by the Calvert formula: AUC x (eGFR + 25). Cockcroft-Gault equation: eGFR (calculated Ccr)= \[(140-age) x weight x 0.85 (if female)\] / (72 x serum Cr). The maximum eGFR for dose calculation is 125 ml/min. In Phase 2 Cohort Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria.

Locations (6)

Chang-Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital (Lin-Kou),

Linkou District, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng-Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan