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.
Powered by
SC CTSI