A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This is a randomized (individuals assigned to study treatment by chance), open-label
(identity of assigned study drug will be known), active-controlled study in adult female
patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal,
or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.
Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria
defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL
combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin)
monotherapy group (Arm B). During the treatment phase, patients will receive study drug
infusions according to 21-day cycles in Arm A and 28-day cycles in Arm B. Treatment will
continue until the occurrence of disease progression or unacceptable treatment toxicity, or
until 2 cycles beyond a confirmed complete response is documented. Up to 2 additional cycles
of study drug are allowed after complete response, at the discretion of the principal
investigator. Efficacy assessments will be evaluated using Response Evaluation Criteria in
Solid Tumors. Disease assessments, including assessments for patients who discontinue
treatment for reasons other than disease progression, will be performed until disease
progression, the start of subsequent anticancer therapy, withdrawal of consent, or the
clinical cutoff date. Collection of survival status will continue until at least 514 deaths
have been observed. Serial pharmacokinetic (PK) samples will be collected in a subset of
patients who voluntarily consent to the PK portion of the study. Safety will be monitored
throughout the study. An interim analysis of overall survival (OS) will be performed after
approximately 308 participants have died. The final analysis of OS will occur when
approximately 514 deaths have been observed.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been observed, whichever is later
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100983
NCT01846611
June 2013
October 2018
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
McLean, Virginia 22101 | |
Little Rock, Arkansas 72205-7199 | |
Hackensack, New Jersey 07601 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Indianapolis, Indiana | |
Tulsa, Oklahoma | |
Providence, Rhode Island 02908 |