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Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trabectedin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Progression Free Survival by Prior Antiangiogenic Treatment | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Progression Free Survival by BRCA1/2 Status | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Tumor Response | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa José Pontes | PharmaMar | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O.L.V. Aalst | Aalst | Flanders | 164-9300 | Belgium | ||
| AZ Maria Middelares |
Not provided
A total of 220 patients treated according to standard local clinical practice in 57 sites across Italy, Spain, Germany, France, and Belgium have been enrolled in the study. The first patient was included in the study on 28 July 2015. Data were collected between 26 January 2015, date of first patient trabectedin administration (prior treatment before inclusion in the study) and 18 September 2019, date of last patient last visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prior Use of Antiangiogenics | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| FG001 | No Prior Use of Antiangiogenics |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2018 | Jun 4, 2021 |
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| From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Progression Free Survival by Platinum Sensitivity | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
| From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) |
| Best Response by Prior Antiangiogenic Treatment | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) |
| Overall Survival | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Overall Survival by Prior Antiangiogenic Treatment | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Overall Survival by BRCA1/2 Status | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Overall Survival by Platinum Sensitivity | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
| Change From Baseline to Best Post-baseline ECOG Performance Status Score | Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) |
| Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) |
| Ghent |
| Flanders |
| 1026-9000 |
| Belgium |
| Centre Hospitalier de Jolimont | La Louvière | Henao | 7100 | Belgium |
| CHU Ambroise-Paré | Mons | Henao | 02-7000 | Belgium |
| Centre Hospitalier de Wallonie Picarde | Tournai | Henao | 807500 | Belgium |
| CHIREC - Cancer Institute | Brussels | 32-1180 | Belgium |
| Centre d'Oncologie et de Radiothérapie du Parc | Dijon | Borgoña | 21000 | France |
| Clinique Saint Jean | Toulon | Provence | 83000 | France |
| Institut d'Oncologie Hauts-de-Seine Nord | Neuilly-sur-Seine | Seine | France |
| Clinique Victor Hugo - Centre Jean Bernard | Le Mans | Sharte | 72000 | France |
| Clinique de l'Europe | Amiens | 80000 | France |
| Medipole de Savoie | Challes-les-Eaux | 73190 | France |
| Oncologie médicale du Val d'Oise | Osny | 95520 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Strasbourg Oncologie Libérale Centre de radiothérapie | Strasbourg | 67000 | France |
| Onkologie Westerstede | Westerstede | Ammerland | 26655 | Germany |
| Klinikum Kempten | Kempten (Allgäu) | Bavaria | 87439 | Germany |
| Städtisches Klinikum | Solingen | Düsseldorf | 42653 | Germany |
| Klinikum Darmstadt Frauenklinik | Darmstadt | Hesse | 64283 | Germany |
| Brustzentrum | Wetzlar | Hesse | 35578 | Germany |
| Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin | Homburg/Saar | Homburg | 66424 | Germany |
| Onkologische Schwerpunktpraxis | Dresden | Saxony | 1307 | Germany |
| Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie | Georgsmarienhutte | Saxony | 49124 | Germany |
| Klinikum St. Marien Amberg | Amberg | 92224 | Germany |
| Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde | Arnsberg | 59759 | Germany |
| Onkologische Gemeinschaftspraxis | Bottrop | 46236 | Germany |
| Städt. Klinik Dortmund, Frauenklinik | Dortmund | 44137 | Germany |
| Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH | München | 80804 | Germany |
| Praxis Dr. Rene Schubert | Scheibenberg | 09481 | Germany |
| Kreiskrankenhaus Torgau | Torgau | 04860 | Germany |
| IRCCS Casa Sollievo Della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Centro Riferimento Oncologico di Aviano | Aviano | Pordenone | 33081 | Italy |
| Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula | Monserrato | Sardinia | 09042 | Italy |
| Ospedale S.Maria d. Misericordia | Bergamo | Savona | 24047 | Italy |
| Ospedale Cardinal Massaia | Asti | 14100 | Italy |
| Istituto Tumori Giovanni Paolo II IRCCS | Bari | 70124 | Italy |
| Azienda Ospedaliera Gaetano Rummo | Benevento | 82100 | Italy |
| A. O. Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Ospedale S. Anna | Como | 22020 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| A.O. Sacco | Milan | 20157 | Italy |
| Istituto Nazionale Tumori IRCCS Pascale | Naples | 80131 | Italy |
| A.O.U. di Parma | Parma | 43126 | Italy |
| Policlinico Universitario Agostino Gemelli Università Cattolica di Roma | Roma | 00168 | Italy |
| Ospedale Gradenigo | Torino | 10153 | Italy |
| Ospedale CÃ Foncello | Treviso | 31100 | Italy |
| Complejo Hospitalario de Jaén | Jaén | Jaen | 23007 | Spain |
| Hospital Doctor NegrÃn | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital de León | León | León | 28040 | Spain |
| Hospital Infanta Cristina | Parla | Madrid | 06080 | Spain |
| Hospital Xeral-CÃes de Vigo | Vigo | Pontevedra | 36204 | Spain |
| Hospital Universitario de La Laguna | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital de Galdakao | Galdakao | Vizcaya | 48960 | Spain |
| Complejo Hospitalario de La Coruña | A Coruña | 15006 | Spain |
| Hospital Sant Pau | Barcelona | 08026 | Spain |
| Hospital de Reus | Barcelona | 43204 | Spain |
| MD Anderson | Madrid | 28033 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 07198 | Spain |
| Hospital Virgen Macarena | Seville | 41071 | Spain |
| Instituto Valenciano de OncologÃa | Valencia | 46009 | Spain |
| Hospital ClÃnico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| COMPLETED |
|
| NOT COMPLETED |
|
|
2 patients enrolled did not receive PLD
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prior Use of Antiangiogenics | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| BG001 | No Prior Use of Antiangiogenics | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Weight | 19 patients not evaluated | Median | Full Range | Kg |
| ||||||||||||||
| Height | 19 patients not evaluated | Median | Full Range | cm |
| ||||||||||||||
| Calculated body surface area | 24 patients not evaluated | Median | Full Range | m^2 |
| ||||||||||||||
| Investigator reported body surface area | 24 patients not evaluated | Median | Full Range | m^2 |
| ||||||||||||||
| Tumor grade at diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Histopathology at initial ovarian cancer diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Platinum sensitivity | Count of Participants | Participants |
| ||||||||||||||||
| BRCA 1/2 status tested | Count of Participants | Participants |
| ||||||||||||||||
| ECOG performance status | Eastern Cooperative Oncology Group performance status: 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead | Count of Participants | Participants |
| |||||||||||||||
| Prior surgery | Count of Participants | Participants |
| ||||||||||||||||
| Surgery residual disease | Count of Participants | Participants |
| ||||||||||||||||
| Prior radiotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Prior chemotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Number of prior chemotherapy lines | Count of Participants | Participants |
| ||||||||||||||||
| Best response to prior therapy regimen | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Posted | Median | 95% Confidence Interval | months | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
|
|
| ||||||||||||||||||||||||||
| Primary | Progression Free Survival by Prior Antiangiogenic Treatment | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Posted | Median | 95% Confidence Interval | months | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
| ||||||||||||||||||||||||||||
| Primary | Progression Free Survival by BRCA1/2 Status | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Posted | Median | 95% Confidence Interval | months | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| |||||||||||||||||||||||||||
| Primary | Progression Free Survival by Platinum Sensitivity | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Posted | Median | 95% Confidence Interval | months | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
| ||||||||||||||||||||||||||||
| Secondary | Best Tumor Response | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | Posted | Count of Participants | Participants | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| ||||||||||||||||||||||||||||
| Secondary | Best Response by Prior Antiangiogenic Treatment | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | Posted | Count of Participants | Participants | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) |
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | Posted | Median | 95% Confidence Interval | months | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival by Prior Antiangiogenic Treatment | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | Posted | Median | 95% Confidence Interval | months | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival by BRCA1/2 Status | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | Posted | Median | 95% Confidence Interval | months | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival by Platinum Sensitivity | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. | Posted | Median | 95% Confidence Interval | months | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Best Post-baseline ECOG Performance Status Score | Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead | Posted | Count of Participants | Participants | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead | Posted | Count of Participants | Participants | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) |
|
From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Two patients were excluded from the safety set because of missing PLD treatment data
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prior Use of Antiangiogenics | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | 30 | 129 | 23 | 129 | 106 | 129 |
| EG001 | No Prior Use of Antiangiogenics | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | 12 | 89 | 14 | 89 | 78 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood electrolytes decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Off label use | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit. | Pharma Mar S.A. | 0034 91846 60 00 | clinicaltrials@pharmamar.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2019 | Jun 4, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| 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 |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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