Ovarian Cancer Clinical Trial
Official title:
A Randomized, Open Label, Single-Dose, Two-Cycle Crossover Study to Assess Bioequivalence of Test and Reference Formulations of Doxorubicin Hydrochloride Liposome Injection in Female Patients With Ovarian Cancer
This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment,
two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference
(R) formulations of doxorubicin hydrochloride liposome injection in female patients with
ovarian cancer.
Each patient will be randomized to one of two treatment sequences (RT or TR) according to a
randomization scheme prepared prior to the start of the trial.There will be at least 4-week
apart between each single-dose administration. Serial blood samples for determination of
free doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK
analysis will be obtained in each cycle.
The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products
of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate
bioequivalence.
This study has an adaptive 2-stage design. Bioequivalence based on encapsulated doxorubicin
will be tested at the end of Stage 1 . An interim analysis of free doxorubicin will be
performed at the end of Stage 1 . If needed, the study may continue into Stage 2 with
additional number of ovarian cancer patients determined based on the interim analysis; and a
final evaluation of bioequivalence for free doxorubicin will be performed at the end of
Stage 2. Each patient will be randomized to one of two treatment sequences (RT or TR)
according to a randomization scheme prepared prior to the start of the trial. Serial blood
samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma
concentrations for PK analysis will be obtained in each cycle.
The 90% confidence intervals on the GMR（geometric mean ratio） of test to reference products
of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate
bioequivalence.
Safety data will be summarized and listed. Adverse events will be coded and classified by
system organ class and preferred term using Common Terminology Criteria for Adverse Events.
A summary of all drug-related adverse events will also be generated. Clinical laboratory
data will be summarized descriptively and listed by treatment group. The change from pre
dose to the end of the study will also be summarized. Prior and concomitant medications will
be coded with the World Health Organization Drug Dictionary and listed. Vital signs and
electrocardiogram data will be summarized and listed by dose group and visit.
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