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

NCT05385861 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • GEP-NET

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.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Tsang-Wu Liu · Taiwan Cooperative Oncology Group, NHRI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385861 on ClinicalTrials.gov