Clinical Trials List
Protocol NumberPEP0210
NCT Number(ClinicalTrials.gov Identfier)NCT03810742
Completed
2018-10-01 - 2021-03-31
Phase I
Recruiting3
Terminated1
Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
-
Trial Applicant
Linical
-
Sponsor
PharmaEngine
-
Trial scale
Taiwan Multiple Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chang-Fang Chiu Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Su-Peng Yeh Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Ming-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wu-Chou Su Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- Yan-Shen Shan Division of Hematology & Oncology
- Hui-Jen Tsai Division of Hematology & Oncology
- Nai-Jung Chiang Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Li-Tzong Chen Division of Hematology & Oncology
- Kwang-Yu Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- SHIH-HUNG YANG 未分科
- Kun-Huei Yeh Division of Hematology & Oncology
- Chiun Hsu Division of Hematology & Oncology
- 陳國興 Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- 梁逸歆 Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Yan-Shen Shan Division of Hematology & Oncology
- Hui-Jen Tsai Division of Hematology & Oncology
- Kwang-Yu Chang Division of Hematology & Oncology
- Li-Tzong Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Solid tumors
Objectives
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 Objectives
• to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®) and TAS-102 (LONSURF®)
• to study the pharmacokinetics of the combination therapy
Test Drug
nal-IRI
Active Ingredient
Irinotecan Hydrochloride
Trifluorothymidine, Tipiracil hydrochloride
Trifluorothymidine, Tipiracil hydrochloride
Dosage Form
injection
film-coated tablet
film-coated tablet
Dosage
5mg/mL,10mL/Vial
15mg, 20 mg
15mg, 20 mg
Endpoints
Primary Outcome Measures :
Determination of Dose Limiting Toxicities (DLT) [ Time Frame: 12 months ]
to find the Dose Limiting Toxicity (DLT) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
Evaluation of Safety profile of nal-IRI and TAS-102 - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]
Incidence of Treatment-Emergent Adverse Events [Safety] of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) according to NCI-CTCAE version 5.0
Secondary Outcome Measures :
Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 24 months ]
the objective tumor rate by using RECIST v1.1
Pharmacokinetics study - (Cmax) [ Time Frame: 6 months ]
Concentration of Peak Plasma (Cmax)
Pharmacokinetics study - (Tmax) [ Time Frame: 6 months ]
maximum concentration of the time taken to reach the (Tmax).
Pharmacokinetics study - (T1/2) [ Time Frame: 6 months ]
time of C max to drop in half taken (T1/2)
Pharmacokinetics study - (AUC0→t) [ Time Frame: 6 months ]
area of the plasma concentration versus time curve (AUC0→t).
Pharmacokinetics study - (AUC0→∞) [ Time Frame: 6 months ]
area of the plasma concentration versus under curve (AUC0→∞)
Pharmacokinetics study - (CL) [ Time Frame: 6 months ]
rate of clearance (CL)
Determination of Dose Limiting Toxicities (DLT) [ Time Frame: 12 months ]
to find the Dose Limiting Toxicity (DLT) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
Evaluation of Safety profile of nal-IRI and TAS-102 - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]
Incidence of Treatment-Emergent Adverse Events [Safety] of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) according to NCI-CTCAE version 5.0
Secondary Outcome Measures :
Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 24 months ]
the objective tumor rate by using RECIST v1.1
Pharmacokinetics study - (Cmax) [ Time Frame: 6 months ]
Concentration of Peak Plasma (Cmax)
Pharmacokinetics study - (Tmax) [ Time Frame: 6 months ]
maximum concentration of the time taken to reach the (Tmax).
Pharmacokinetics study - (T1/2) [ Time Frame: 6 months ]
time of C max to drop in half taken (T1/2)
Pharmacokinetics study - (AUC0→t) [ Time Frame: 6 months ]
area of the plasma concentration versus time curve (AUC0→t).
Pharmacokinetics study - (AUC0→∞) [ Time Frame: 6 months ]
area of the plasma concentration versus under curve (AUC0→∞)
Pharmacokinetics study - (CL) [ Time Frame: 6 months ]
rate of clearance (CL)
Inclution Criteria
Inclusion Criteria
In order for study inclusion, patients must have:
1. Ages between 20 to 70 years old
2. Histologically or cytologically confirmed malignant solid tumors which are
advanced or metastatic, have failed standard treatment or have no standard
treatment currently available
3. ECOG Performance status 0 or 1
4. Normal ECG or ECG without any clinically significant findings
5. Adequate hematologic parameters, and hepatic and renal function
i. WBC 3000/μL and 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. ALT 3 x ULN
vii. Serum creatinine 1.5 x ULN
In order for study inclusion, patients must have:
1. Ages between 20 to 70 years old
2. Histologically or cytologically confirmed malignant solid tumors which are
advanced or metastatic, have failed standard treatment or have no standard
treatment currently available
3. ECOG Performance status 0 or 1
4. Normal ECG or ECG without any clinically significant findings
5. Adequate hematologic parameters, and hepatic and renal function
i. WBC 3000/μL and 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. ALT 3 x ULN
vii. Serum creatinine 1.5 x ULN
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria:
1. Received prior nal-IRI (ONIVYDE®
) or TAS-102 (LONSURF®
) therapy
2. Known hypersensitivity to any of the components of nal-IRI, other liposomal
products, fluoropyrimidines or leucovorin
3. Have liver cirrhosis with Child-Pugh B or Child-Pugh C
4. With active CNS metastasis (indicated by clinical symptoms, cerebral edema,
steroid requirement, or progressive growth)
5. With clinically significant gastrointestinal disorder including hepatic disorders,
bleeding, inflammation, occlusion, or diarrhea > grade 1
6. Life expectancy of less than 3 months
7. Use any anti-cancer or investigational product within 14 days prior to the first
date of study dosing
8. History of any second malignancy in the lastest 5 years except curatively
treated non-melanoma skin cancer or treated cervical carcinoma in situ
9. 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
10. 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)
11. Pregnant or breastfeeding women
Patients will be excluded from the study if they meet any of the following criteria:
1. Received prior nal-IRI (ONIVYDE®
) or TAS-102 (LONSURF®
) therapy
2. Known hypersensitivity to any of the components of nal-IRI, other liposomal
products, fluoropyrimidines or leucovorin
3. Have liver cirrhosis with Child-Pugh B or Child-Pugh C
4. With active CNS metastasis (indicated by clinical symptoms, cerebral edema,
steroid requirement, or progressive growth)
5. With clinically significant gastrointestinal disorder including hepatic disorders,
bleeding, inflammation, occlusion, or diarrhea > grade 1
6. Life expectancy of less than 3 months
7. Use any anti-cancer or investigational product within 14 days prior to the first
date of study dosing
8. History of any second malignancy in the lastest 5 years except curatively
treated non-melanoma skin cancer or treated cervical carcinoma in situ
9. 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
10. 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)
11. Pregnant or breastfeeding women
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
60 participants
