Study Overview
The study aimed to characterize the pharmacokinetic profile and to assess the bioequivalence of Liposomal doxorubicin (TEST) in comparison to RLD (Caelyx® – liposomal doxorubicin), in patients with advanced ovarian cancer or metastatic breast cancer, providing valuable insights into potential advancements in oncology treatments. The study is intended for ANVISA submission, ensuring compliance with the necessary standards.
Study Design
A Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover Bioequivalence Study between two formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) in Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer.
Challenges and Solutions:
| Challenges | Solutions |
|---|---|
| Identification of Patients with Advanced Ovarian Cancer or Metastatic Breast Cancer and patient retention for PK study | Identification of investigator sites with a substantial patient pool, excellent clinical trial experience, and the requisite infrastructure for the PK study. |
| Storage of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL:Store between 2°– 8°C (36°-46°F) in a refrigerator. Do not freeze.Freezing or temperature excursion may lead to a change in Liposome formulation and could result in toxic effects. | A comprehensive cold chain management to ensure the integrity of the investigational products.A strict protocol to prohibit the use of investigational products in case of any temperature excursion. |
| IMP Preparation and Administration within Stipulated Timeframe | Close oversight of IMP preparation and robust calculations.Utilization of infusion pumps for accurate and timely IMP administration.Conducting in-depth training for the site team on IMP calculations and administration, including on-site demonstrations to ensure proper handling. |
| Handling of PK samples considering the sensitivity of the molecule, as mishandling can lead to leaching of liposomes. | A dedicated, trained, and experienced team of Phlebotomists was deployed to the site to perform all PK sample-related activities, from collection to storage.Continuous oversight of PK sample storage to ensure the preservation and integrity of the sensitive molecules. |
Achievements
- 74 patients were successfully randomized within a remarkable period of 3 months, demonstrating effective patient enrollment strategies.
- Efficient trial execution with a timeline of just 6.5 months, starting from the first site initiation visit (SIV) until the last patient’s last visit.
Proven Track Record in Oncology Clinical Trials
| 59 Studies | 4238 Patients | 876 sites |
|---|
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