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

NCT05385861 | Enrolling By Invitation Phase 1

• 1 other identifier: T2222
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (2)

• MTD and RP2D

  • in phase 1 cohort, to determine MTD (maximum tolerated dose) and recommended phase 2 dose (RP2D)

  3 Years

• tumor response rate

  • in phase 2 cohort, to assess the objective tumor response rate

  3 Years

Secondary Outcomes (2)

• PFS and OS

  3 Years

• To explore the treatment-related adverse events as assessed by CTCAE v5.0

  3 Years

Study Arms (1)

nal-IRI (ONIVYDE®) and Carboplatin

EXPERIMENTAL

nal-IRI (ONIVYDE®) and Carboplatin

Drug: nanoliposomal irinotecan plus carboplatin

Interventions

nanoliposomal irinotecan plus carboplatin DRUG

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.

Also known as: Phase 1 cohort, Phase 2 Cohort

nal-IRI (ONIVYDE®) and Carboplatin

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed locally advanced or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma.
• patients either are chemotherapy-naive or had received adjuvant chemotherapy \> 6 months before recurrence.
• at least one measurable lesion according to the RECIST version 1.1..
• patients were aged 20 to 80 years with ECOG performance status of 0 to 1.
• patients had a life expectancy ≥ 3 months.
• patients had adequate renal function with defined as serum creatinine ≤ 2 times the upper limit of normal (ULN) or eGFR (calculated Ccr) ≥ 45 mL/min.
• patients had adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and alanine aminotransferase ≤ 2.5 the ULN and ≤ 5 times the ULN within the setting of liver metastases.
• patients had adequate bone marrow function, defined as an absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 9 g/dL.
• Normal ECG or abnormal ECG without any clinical significantly findings.
• Able to understand and sign an informed consent (or have a legal representative who is able to do so).

You may not qualify if:

• a history of palliative chemotherapy or disease recurrence \< 6 months from the time of last adjuvant chemotherapy and/or radiotherapy.
• known hypersensitivity to liposome product, irinotecan or carboplatin.
• receipt of major surgery within the past 4 weeks before study enrollment.
• With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea \> grade 2.
• concurrent severe infection with intravenous systemic antibiotics treatment.
• severe, uncontrolled medical condition including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.
• another previous malignancy diagnosed within the past 5 years except for nonmelanoma skin cancer or stage I cervical cancer.
• active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti-convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.
• psychiatric illness or social situation that would preclude study compliance
• women with pregnant or breast feeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative).

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator

Study Sites (6)

Chang-Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital (Lin-Kou),

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Interventions

irinotecan sucrosofate; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Tsang-Wu Liu

  Taiwan Cooperative Oncology Group, NHRI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: an investigator-initiated, single-arm phase 1/2 study

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 23, 2022
• Study Start: August 14, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TW (6)