Status:
COMPLETED
Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
Lead Sponsor:
PharmaEngine
Conditions:
Refractory Solid Tumors
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers
Detailed Description
Primary Objectives * to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) * to evaluate the toxicity profile of the combination therapy Secondary...
Eligibility Criteria
Inclusion
- Ages between 20 to 70 years old
- Histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed standard treatment or have no standard treatment currently available
- ECOG performance status 0 or 1
- Normal ECG or ECG without any clinically significant findings
- Adequate hematologic parameters, and hepatic and renal function i. White blood cell (WBC) count 3000/μL and absolute neutrophil count (ANC) 1500/μL ii. Platelet counts 100,000/μL without platelet transfusion within 14 days iii. Hemoglobin level 10 g/dL iv. Serum total bilirubin- within normal range v. Serum albumin 3.0 g/dL vi. Serum alanine aminotransferase (ALT) 3 x the upper limit of normal (ULN) vii. Serum creatinine 1.5 x ULN
Exclusion
- Received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) therapy
- Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
- Have liver cirrhosis with Child-Pugh B or Child-Pugh C
- With active CNS metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- With clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 1
- Life expectancy of less than 3 months
- Use any anti-cancer or investigational product within 14 days prior to the first date of study dosing
- History of any second malignancy in the latest 5 years except curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, and psychiatric illness or social situation that would preclude study compliance
- Homozygous for the UGT1A1 28 allele (TA7/TA7), homozygous for UGT1A1 6 allele (A/A), or double heterozygous for both UGT1A1 28 allele (TA6/TA7) and UGT1A1 6 allele (G/A) (only for dose-finding phase)
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03810742
Start Date
March 5 2019
End Date
October 25 2023
Last Update
November 18 2023
Active Locations (2)
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1
China Medical University Hospital
Taichung, Taiwan
2
National Cheng Kung University Hospital
Tainan, Taiwan