Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113607
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2005-06-09
Brief Title:
An Efficacy and Safety Study for Yondelis Trabectedin in Patients With Advanced Relapsed Ovarian Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXILCAELYX and YONDELIS With DOXILCAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the progression-free survival PFS of the combination of trabectedin DOXIL with DOXIL monotherapy in patients with ovarian cancer
Detailed Description:
This is a multicenter open-label all people know the identity of the intervention randomized study medication is assigned by chance Phase 3 study comparing the combination of trabectedin DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer who were previously treated and for whom first-line platinum-based chemotherapy regimen has failed Approximately 650 patients will be randomly assigned to 1 of the treatment arms DOXIL and DOXIL trabectedin over 2 years At the time of randomization patients will be stratified on the basis of platinum sensitivity of disease sensitive or resistant and baseline Eastern Cooperative Oncology Group performance status score 0 to 1 or 2 Safety will be evaluated on the basis of adverse events clinical laboratory tests physical examination vital signs assessment and cardiovascular safety assessment An interim analysis of overall survival will be performed in conjunction with progression-free survival analysis during the study Treatment will be continued until disease progression occurred or until patients experienced a confirmed complete response for at least 2 cycles Continuation of treatment in select individual patients beyond this study end date will be allowed if the investigator determined that the patient is benefiting from treatment is eligible to receive further therapy and consents to treatment If disease progression has not occurred at treatment termination then disease assessment will continue every 8 weeks until there is evidence of disease progression or death or until the clinical data cutoff date or until the start of first subsequent anticancer therapy whichever is earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-005276-16 | EUDRACT_NUMBER | Johnson Johnson Pharmaceutical Research Development LLC | None |
| ET743-OVA-301 | OTHER | None | None |