Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810742
Recruitment Status : Active, not recruiting
First Posted : January 22, 2019
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
PharmaEngine

Tracking Information
First Submitted Date  ICMJE December 21, 2018
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date September 17, 2021
Actual Study Start Date  ICMJE March 5, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
Official Title  ICMJE Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Solid Tumors
Intervention  ICMJE Drug: Nanoliposomal Irinotecan
Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
Other Name: TAS-102
Study Arms  ICMJE Experimental: Nanoliposomal Irinotecan + TAS-102
different dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
Intervention: Drug: Nanoliposomal Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 16, 2021)
44
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
57
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810742
Other Study ID Numbers  ICMJE PEP0210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party PharmaEngine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PharmaEngine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chia-Chi Lin, MD National Taiwan University Hospital, Taipei, Taiwan
PRS Account PharmaEngine
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP