Phase I trial, Multiple centers, open-label, non-randomized single-arm study
1. Patients with age 20-85 years old.
2. Cytologically or histologically confirmed solid malignancies which are locally advanced, recurrent or metastatic diseases. The disease cannot be cured by surgical intervention or local therapies.
3. The malignancies are refractory to standard systemic therapy or there is no available systemic therapy.
a. Dose escalation phase (cohort 1): non-small cell lung cancer, small cell lung cancer, gastric cancer, neuroendocrine carcinoma, biliary tract cancer (including intrahepatic cholangiocarcinoma [CCA], extrahepatic CCA, gallbladder cancer, ampullary cancer), ovarian cancer, esophageal cancer, thymoma or thymic carcinoma.
1. Patients who have major surgery, radiotherapy or other systemic chemotherapy or immunotherapy within 3 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
2. Patient with history of severe allergy to liposomal irinotecan (nal-IRI; ONIVYDE®) or cisplatin.
3. Significant cardiovascular impairment: (1) history of congestive heart failure greater than New York Heart Association (NYHA) Class II, left ventricular ejection fraction< 50%; or (2) unstable angina, myocardial infarction or stroke within 6 months; or (3) uncontrolled cardiac arrhythmia.
4. Patients with electrolyte abnormalities that have not been corrected.
Single group
Liposomal Irinotecan Plus Cisplatin
DrugLiposomal irinotecan and cisplatin are administered intravenously on Days 1 and 15 of each 28-day cycle.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of liposomal irinotecan (nal-IRI) in combination with cisplatin in patients with advanced or metastatic solid malignancies.
Objective Response Rate (ORR) by RECIST Version 1.1
Objective response rate (ORR) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Every 8 weeks from first dose until documented disease progression or death from any cause, whichever occurs first.
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from the first dose to documented disease progression or death from any cause, whichever occurs first.
Safety Profile
Safety profile assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE Version 5.0.
Overall survival (OS)
OS will be measured from the start date of study treatment to the date of death.
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National Health Research Institutes, Taiwan
Lead sponsor
China Medical University Hospital
Collaborator
National Taiwan University Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
Mackay Memorial Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
Taichung Veterans General Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
