NCT03681548

A Study of Doxorubicin Hydrochloride Liposome Injection in Subjects With Ovarian Cancer.

A Randomized, Open Label, Two Arm, Single Dose, Crossover, Bioequivalence Study of Ayana Pharma's Doxorubicin Hydrochloride Liposome Injection (LC-101) (Investigational Product) and the US Reference Standard Doxorubicin Hydrochloride Liposome Injection (Sun Pharma), in Subjects With Ovarian Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ayana Pharma Ltd., · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal injection therapy .

Detailed description

This study is a randomized, open label, two arm, single dose, crossover bioequivalence study. This study will be conducted in female subjects aged 18 to 65 years diagnosed with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with Doxorubicin Hydrochloride Liposome Injection product. Each subject will be randomized to one of the two treatment sequences (RT or TR) according to a randomization scheme prepared prior to start of the trial. Serial blood samples for determination of free and liposomal encapsulated doxorubicin plasma concentration for PK analysis will be obtained in each cycle., This study has an adaptive 2-stage design. A sufficient number of subjects with ovarian cancer shall be recruited to have approximately 42 evaluable subjects completing all follow up procedures (Stage 1). An interim analysis of free and encapsulated doxorubicin will be performed at the end of Stage 1. If the bioequivalence of encapsulated and free doxorubicin has been established, then the study will be stopped. Otherwise, the study may continue into Stage 2 with additional number of ovarian cancer subjects. A final evaluation of bioequivalence based on free and encapsulated doxorubicin will be performed at the end of Stage 2 and will include all enrolled subjects completing the study. Bioequivalence criteria: the 94.12% confidence interval of the ratio of geometric means of TEST to REFERENCE for Cmax, AUC0-t, AUC0-∞, for free and encapsulated doxorubicin should be between 80.00% and 125.00%.

Conditions

• Ovarian Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Doxorubicin Hydrochloride Liposome Injection	50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 1 patients will receive either reference or test product, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation

Timeline

• Start date: 2018-08-29
• Primary completion: 2019-02-08
• Completion: 2019-03-07
• First posted: 2018-09-24
• Last updated: 2019-11-20

Locations

15 sites across 1 country: India

Regulatory

• FDA-regulated drug study