drugset / Trial / NCT05385861
Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET
Phase 1/2
Enrolling by invitation
52 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabChina Medical University Hospital · collabKaohsiung Medical University Chung-Ho Memorial Hospital · collabNational Cheng-Kung University Hospital · collabTaipei Veterans General Hospital, Taiwan · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-14
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 4 unknown | Intravenous |
| Subject | Irinotecan | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 100 mg/m2 | Intravenous |