A Pivotal Bioequivalence Study of DOXIL/CAELYX Manufactured at a New Site in Subjects With Advanced or Refractory Solid Malignancies Including Subjects With Ovarian Cancer.
This is a randomized (individuals will be assigned in a random order to study treatment
sequences), open-label (identity of assigned treatment sequences will be known), single
dose, 2-cycle, crossover (patients will receive both treatments in a random order)
bioequivalence study of DOXIL/CAELYX (doxorubicin HCL) in patients with advanced or
refractory solid malignancies (including patients with ovarian cancer). This study has an
adaptive 2-stage design. Bioequivalence based on encapsulated doxorubicin will be tested at
the end of Stage 1 using data from at least 24 ovarian cancer patients. An interim analysis
of free doxorubicin will be performed at the end of Stage 1 using data from 42 patients of
all cancer types. The study may continue into Stage 2 with additional patients of all cancer
types; and final evaluation of bioequivalence for free doxorubicin will be performed at the
end of Stage 2. The study will include a screening phase followed by an open-label treatment
phase consisting of 2 doxorubicin treatment cycles and an end-of-treatment visit on Cycle 3,
Day 1. Participants may enter an optional extension phase after 2 cycles. Safety will be
monitored throughout the study. Blood samples for pharmacokinetic analysis will be obtained
from all participants at specified times over 29 days after starting each study drug
administration in Cycles 1 and 2 for determination of plasma concentrations of encapsulated
and free doxorubicin.
Interventional
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum observed plasma concentration of encapsulated doxorubicin in participants with ovarian cancer
Predose Day 1 Cycles 1-2; Postdose Cycles 1-2 at 15 min, 30 min, 60 min, 90 min, 95 min, 105 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 72 h, 96 h, 168 h, 336 h, 504 h, 672 h
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100961
NCT01815294
May 2013
February 2016
Name | Location |
---|---|
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 |