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.

Not Applicable

• Conditions: Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified

• Registration Number: CTRI/2023/08/056699
• Lead Sponsor: Mylan Laboratories Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.Timepoint: 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 Measures

Name	Time	Method
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.Timepoint: Safety will be assessed throughout the study, i.e., from signing of ICF to end of study visit.