CTRI/2023/08/056699 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On:
26/11/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
An open-label study comparing the blood concentrations of Irinotecan Liposomal Injection at different times in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
Scientific Title of Study
An open-label, randomized, multi-center, three-period, three-treatment, three-sequence, single-dose, crossover, pharmacokinetic study of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Serviers Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine
Ethics Committee, Unique Hospital Multispeciality and Research Institute
Approved
HCG Central Ethics Committee
Approved
IEC-KCHRC, Kailash cancer and medical centre
Approved
IEC-KIMS Deemed to be University
Approved
IEC-Saveetha Medical College Hospital
Approved
Institutional Ethics Committee Sparsh Hospitals
Approved
Institutional Ethics Committee, AIIMS Bhubaneswar
Approved
Institutional Ethics Committee, Sunshine Global Hospital
Approved
Institutional Ethics committee- Erode Cancer Centre
Approved
Institutional Ethics Committee- HCG Cancer Centre
Approved
Kiran Hospital Ethics Committee
Approved
Medstar Speciality Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Comparator 1: Onivyde, 43 mg/10 mL single dose vial
Comparator 2: Onivyde, 43 mg/10 mL single dose vial
Dosage: 70 mg/m2
Frequency: Single dose
Route of Administration: Intravenous
Duration of therapy: 90 minutes
Intervention
Irinotecan Liposomal Injection, 43 mg/10 mL single dose vial
Dosage: 70 mg/m2
Frequency: Single dose
Route of Administration: Intravenous
Duration of therapy: 90 minutes
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Patient with Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
2. Patients with documented disease progression after prior gemcitabine or gemcitabine-containing therapy, in locally advanced or metastatic setting
3. Patients of 18-75 years of age, must meet age requirements at the time of signing the initial informed consent and the initial study medication administration
4. Males and/or non-pregnant, non-lactating females.
ExclusionCriteria
Details
1. Patients who are known for gene-drug interaction
2. Known hypersensitivity to any of the components of investigational medicinal product, other liposomal products, fluoropyrimidines, or leucovorin.
3. Patients receiving or scheduled to receive strong CYP3A4 inducers
4. Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
5. Intolerance to venipuncture.
6. Donation or loss of blood or plasma: greater than or equal to 350 mL or more within 90 days prior to the initial dose of the study medication.
7. Patients with confirmed novel coronavirus infection (COVID-19).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the bioequivalence of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) & Les Laboratoires Serviers Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) & leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
Primary analysis will be on the pharmacokinetic parameters derived from the plasma concentration data collected from the samples starting on Day 1 (Day of dosing).
Secondary Outcome
Outcome
TimePoints
To evaluate the safety & tolerability of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Serviers Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
Safety will be assessed throughout the study, i.e., from signing of ICF to end of study visit.
Target Sample Size
Total Sample Size="14" Sample Size from India="14" Final Enrollment numbers achieved (Total)= "14" Final Enrollment numbers achieved (India)="14"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A Bioequivalence Study with Mylan’s Irinotecan Liposomal Injection in patient with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
Primary Objective: To evaluate the bioequivalence of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Servier’s Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
Secondary Objective: To evaluate the safety and tolerability of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Servier’s Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine