At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 442 enrolled
Drug / intervention
Lurbinectedin (PM01183) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
In Brief
A Phase 3 clinical trial evaluating Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD), and 1 other intervention for Ovarian Cancer. Completed, enrolled 442 participants across 28 sites.
Detailed Summary
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartMay 2015
Primary CompletionOct 2018
TodayJul 2026
First PostedApr 20, 2015
Enrollment StartMay 1, 2015
Primary CompletionOct 12, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.2 years ago
Interventions
Lurbinectedin (PM01183)drug
Pegylated liposomal doxorubicin (PLD)drug
Topotecandrug