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| ID | Type | Description | Link |
|---|---|---|---|
| GEI-TRAB-2014-01 | Other Identifier | AEMPS |
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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabectedin+ PLD | Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabectedin and Pegylated Liposomal Doxorubicin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate to previous and post-treatment (Percentage of responses (CR+PR) | Percentage of responses (CR+PR) at pretreatment and post-treatment | Up to 12 months |
| Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Laura Vidal, MD | H. Clinic, Barcelona | Principal Investigator |
| Jose M Del Campo, MD | H. Vall d'Hebron, Barcelona | Principal Investigator |
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Percentage of responses ( CR + PR ) to trabectedin - DLP
| Up to 12 months |
| Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD) | Percentage of clinical benefit (CR + PR + SD for at least 4 months) | Up to 12 months |
| Impact of trabectedin - PLD combination in subsequent treatments | Assessment of the impact of treatment with trabectedin - PLD combination at the beginning of subsequent treatments | Up to 12 months |
| Toxicity (adverse events) | type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports | Up to 12 months |
| Comparison between PFS and PFS2 | Comparison of the PFS of prior platinum combination TRB + DLP and subsequent platinum PFS. | Up to 12 months |
| Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies) | Number and Management of hypersensitivity reactions or allergies. | Up to 12 months |
| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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