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

NCT03810742 | Completed Phase 1 DMC

• 1 other identifier: PEP0210
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Determination of Dose Limiting Toxicities (DLT)

  to find the Dose Limiting Toxicity (DLT) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)

  12 months

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

  Incidence of Treatment-Emergent Adverse Events \[Safety\] of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) according to NCI-CTCAE version 5.0

  12 months

Secondary Outcomes (7)

• Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST)

  24 months

• Pharmacokinetics study - (Cmax)

  6 months

• Pharmacokinetics study - (Tmax)

  6 months

• Pharmacokinetics study - (T1/2)

  6 months

• Pharmacokinetics study - (AUC0→t)

  6 months

Study Arms (1)

Nanoliposomal Irinotecan + TAS-102

EXPERIMENTAL

different dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)

Drug: Nanoliposomal Irinotecan

Interventions

Nanoliposomal Irinotecan DRUG

Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)

Also known as: TAS-102

Nanoliposomal Irinotecan + TAS-102

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaEngine: lead

Study Sites (2)

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Interventions

irinotecan sucrosofate; trifluridine tipiracil drug combination

Study Officials

• Chia-Chi Lin, MD

  National Taiwan University Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 22, 2019
• Study Start: March 5, 2019
• Primary Completion: May 4, 2022
• Study Completion: October 25, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)