CompletedPhase 1

Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors

Taiwan44 participantsStarted 2019-03-05

Plain-language 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

Age range20 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Determination of Dose Limiting Toxicities (DLT)

Timeframe: 12 months

Evaluation of Safety profile of nal-IRI and TAS-102 - Incidence of Treatment-Emergent Adverse Events

Timeframe: 12 months

NCT IDNCT03810742

SponsorPharmaEngine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-04

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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