NCT02394015

Brief Summary

Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

March 10, 2015

Last Update Submit

March 26, 2020

Conditions

Ovarian Epithelial Cancer Recurrent

Keywords

Platinum-sensitive Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • Efficacy progression-free survival (PFS)

    Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of progression-free survival ( PFS).

    Up to 12 months

  • Overall survival (OS)

    Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of overall survival (OS ) .

    Up to 12 months

Secondary Outcomes (7)

  • Response rate to previous and post-treatment (Percentage of responses (CR+PR)

    Up to 12 months

  • Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)

    Up to 12 months

  • Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)

    Up to 12 months

  • Impact of trabectedin - PLD combination in subsequent treatments

    Up to 12 months

  • Toxicity (adverse events)

    Up to 12 months

  • +2 more secondary outcomes

Study Arms (1)

Trabectedin+ PLD

Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC.

Drug: Trabectedin and Pegylated Liposomal Doxorubicin

Interventions

Trabectedin and Pegylated Liposomal DoxorubicinDRUG

Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC from October 28, 2009 to October 31, 2014

Trabectedin+ PLD

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have received treatment with trabectedin - DLP for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.

You may qualify if:

  • Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.

You may not qualify if:

  • Patients with records unavailable (lost, empty or not recoverable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Trabectedinliposomal doxorubicin

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Laura Vidal, MD

    H. Clinic, Barcelona

    PRINCIPAL INVESTIGATOR

  • Jose M Del Campo, MD

    H. Vall d'Hebron, Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 20, 2015

Study Start

May 6, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 27, 2020

Record last verified: 2020-03