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

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ClinicalTrials.gov Identifier: NCT03810742
Recruitment Status : Active, not recruiting
First Posted : January 22, 2019
Last Update Posted : December 2, 2022
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Refractory Solid Tumors Drug: Nanoliposomal Irinotecan Phase 1

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 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

A phase 1 study with a classical 3 + 3 dose escalation design. The target population is patients who have pathologically confirmed malignant solid tumors with no standard treatment available.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nanoliposomal Irinotecan + TAS-102
different dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
Drug: Nanoliposomal Irinotecan
Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
Other Name: TAS-102

Primary Outcome Measures :
  1. 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®)

  2. 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 :
  1. 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

  2. Pharmacokinetics study - (Cmax) [ Time Frame: 6 months ]
    Concentration of Peak Plasma (Cmax)

  3. Pharmacokinetics study - (Tmax) [ Time Frame: 6 months ]
    maximum concentration of the time taken to reach the (Tmax).

  4. Pharmacokinetics study - (T1/2) [ Time Frame: 6 months ]
    time of C max to drop in half taken (T1/2)

  5. Pharmacokinetics study - (AUC0→t) [ Time Frame: 6 months ]
    area of the plasma concentration versus time curve (AUC0→t).

  6. Pharmacokinetics study - (AUC0→∞) [ Time Frame: 6 months ]
    area of the plasma concentration versus under curve (AUC0→∞)

  7. Pharmacokinetics study - (CL) [ Time Frame: 6 months ]
    rate of clearance (CL)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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. 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 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 latest 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810742

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China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Sponsors and Collaborators
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Principal Investigator: Chia-Chi Lin, MD National Taiwan University Hospital, Taipei, Taiwan
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Responsible Party: PharmaEngine
ClinicalTrials.gov Identifier: NCT03810742    
Other Study ID Numbers: PEP0210
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents