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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | lurbinectedin (PM01183) |
|
| Arm B | Active Comparator | pegylated liposomal doxorubicin OR topotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurbinectedin (PM01183) | Drug |
| ||
| Pegylated liposomal doxorubicin (PLD) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival by Independent Review Committee | The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment. | Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival by Investigator's Assessment | The primary endpoint was PFS by Investigator's Assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1112 | Peoria | Arizona | United States | |||
| 1102 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407274 | Derived | Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. | |
| 34521554 | Derived | Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11. |
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IC;Age≥18 years;confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer;Platinum-resistant disease;ECOG PS≤2;Adequate hematological, renal, metabolic, and hepatic function
First randomization/first study treatment administration took place on 26JUN2015. The cutoff date for results was 12OCT2018. 534 patients were screened; 442 were randomized at 83 sites/12 countries. 10 patients did not receive the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurbinectedin | 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 4, 2014 | Jan 21, 2020 |
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|
| Topotecan | Drug |
|
| Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years |
| Overall Survival (OS) | Calculated from the date of randomization to the date of death (death event) or last contact (in this case, survival was censored on that date). | From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years |
| Overall Response Rate (ORR) by Independent Review Committee | Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR. | At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years |
| Overall Response Rate by Investigator's Assessment | Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR. | At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years |
| Duration of Response by Independent Review Committee | Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response. Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR. | The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years |
| Duration of Response by Investigator's Assessment | Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response. Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR. | The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years |
| Best Response According to Tumor Marker Evaluation (CA-125) | Best response according to tumor marker evaluation (CA-125): defined as the best response obtained according to GCIG criteria. Tumor marker assessments were performed at baseline and every eight weeks from randomization until evidence of PD. Progression based on serum CA-125 levels was defined on the basis of a progressive serial elevation of serum CA-125 according to: A. Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or B. Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or C. Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart. | At baseline and every eight weeks from randomization until evidence of PD, up to 3 years |
| Greenbrae |
| California |
| United States |
| 1103 | La Jolla | California | United States |
| 1116 | Los Angeles | California | United States |
| 1120 | Los Angeles | California | United States |
| 1113 | Palo Alto | California | United States |
| 1111 | San Francisco | California | United States |
| 1122 | Santa Maria | California | United States |
| 1123 | West Hills | California | United States |
| 1109 | Augusta | Georgia | United States |
| 1104 | Indianapolis | Indiana | United States |
| 1110 | Covington | Louisiana | United States |
| 1124 | Scarborough | Maine | United States |
| 1121 | Brick | New Jersey | United States |
| 1127 | Albany | New York | United States |
| 1105 | New York | New York | United States |
| 1117 | Asheville | North Carolina | United States |
| 1101 | Charlotte | North Carolina | United States |
| 1125 | Charlotte | North Carolina | United States |
| 1108 | Durham | North Carolina | United States |
| 1107 | Columbus | Ohio | United States |
| 1118 | Dayton | Ohio | United States |
| 1119 | Pittsburgh | Pennsylvania | United States |
| 1115 | Greenville | South Carolina | United States |
| 1129 | Nashville | Tennessee | United States |
| 1131 | Fort Worth | Texas | United States |
| 1128 | Houston | Texas | United States |
| 1106 | Charlottesville | Virginia | United States |
| FG001 | Control (PLD or Topotecan) | Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lurbinectedin | 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL |
| BG001 | Control (PLD or Topotecan) | Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual |
| 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body mass index | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG PS | ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead | Count of Participants | Participants |
| |||||||||||||||||
| Primary site | Count of Participants | Participants |
| ||||||||||||||||||
| Histology type | Count of Participants | Participants |
| ||||||||||||||||||
| Histologic grade | Count of Participants | Participants |
| ||||||||||||||||||
| BRCA status | Count of Participants | Participants |
| ||||||||||||||||||
| Intestinal sub-occlusion | Count of Participants | Participants |
| ||||||||||||||||||
| Clinically evident ascites | Count of Participants | Participants |
| ||||||||||||||||||
| Radiological presence of ascites | Count of Participants | Participants |
| ||||||||||||||||||
| Prior radiotherapy | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Cytoreductive surgery | Count of Participants | Participants |
| ||||||||||||||||||
| Other prior surgical procedures | Count of Participants | Participants |
| ||||||||||||||||||
| Weight | Median | Full Range | Kg |
| |||||||||||||||||
| Height | Median | Full Range | cm |
| |||||||||||||||||
| Body Surface Area | Median | Full Range | m^2 |
| |||||||||||||||||
| Body mass index | Median | Full Range | kg/m^2 |
| |||||||||||||||||
| First diagnosis to randomization | Median | Full Range | months |
| |||||||||||||||||
| Sites involved | Median | Full Range | number of sites |
|
| 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 by Independent Review Committee | The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment. | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival by Investigator's Assessment | The primary endpoint was PFS by Investigator's Assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment. | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years |
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| Secondary | Overall Survival (OS) | Calculated from the date of randomization to the date of death (death event) or last contact (in this case, survival was censored on that date). | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years |
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| Secondary | Overall Response Rate (ORR) by Independent Review Committee | Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR. | Posted | Count of Participants | Participants | At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate by Investigator's Assessment | Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR. | Posted | Count of Participants | Participants | At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by Independent Review Committee | Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response. Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR. | Patients who have CR or PR | Posted | Median | 95% Confidence Interval | months | The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by Investigator's Assessment | Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response. Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments. Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR. | Patients who have CR or PR | Posted | Median | 95% Confidence Interval | months | The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years |
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| Secondary | Best Response According to Tumor Marker Evaluation (CA-125) | Best response according to tumor marker evaluation (CA-125): defined as the best response obtained according to GCIG criteria. Tumor marker assessments were performed at baseline and every eight weeks from randomization until evidence of PD. Progression based on serum CA-125 levels was defined on the basis of a progressive serial elevation of serum CA-125 according to: A. Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or B. Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or C. Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart. | Posted | Count of Participants | Participants | At baseline and every eight weeks from randomization until evidence of PD, up to 3 years |
|
Participants were assessed through study completion, approximately 3 years
A total of 432 of 442 patients randomized in this study were treated (n=219 in the Lurbinectedin arm; n=213 in the Control arm [PLD or topotecan]) and therefore were evaluable for safety. Ten patients were not treated after randomization: two in the Lurbinectedin arm and eight in the Control arm (PLD or topotecan).
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 | Lurbinectedin | 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL | 170 | 219 | 92 | 219 | 212 | 219 |
| EG001 | Control (PLD or Topotecan) | Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual | 171 | 213 | 85 | 213 | 211 | 213 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiorespiratory arrest | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperclycemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pharma Mar S.A. | Pharma Mar S.A. | 0034918466000 | clinicaltrials@pharmamar.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2017 | Jan 21, 2020 | 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 |
|---|---|
| C568606 | PM 01183 |
| C506643 | liposomal doxorubicin |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Romania |
|
| Spain |
|
| United Kingdom |
|
| Austria |
|
| Belgium |
|
| Bulgaria |
|
| Czechia |
|
| France |
|
| Hungary |
|
| Italy |
|
| Serbia |
|
| 20-25 kg/m^2 |
|
| 25-30 kg/m^2 |
|
| >30 kg/m^2 |
|
| Unknown |
|
| PS 1 |
|
| PS 2 |
|
| Fallopian |
|
| Peritoneal |
|
| Endometrioid |
|
| Clear cell |
|
| Mucinous |
|
| Other |
|
| Moderately differentiated |
|
| Poorly differentiated/Undifferentiated |
|
| Unknown |
|
| BRCA2 |
|
| Not mutated |
|
| Unknown |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| PFS at 6 months |
| 24.3 |
| 2-Sided |
| 95 |
| 18.4 |
| 30.7 |
Percent of Participants |
| Superiority |
| PFS (%) at 6 months | PFS at 6 months | 27.5 | 2-Sided | 95 | 20.9 | 34.4 | Percent of Participants | Superiority |
| PFS (%) at 6 months between treatments | Normal approximation | 0.5032 | Superiority |
| PFS (%) at 12 months | PFS at 12 months | 8.3 | 2-Sided | 95 | 4.7 | 13.3 | Percent of Participants | Superiority |
| PFS (%) at 12 months | PFS at 12 months | 7.0 | 2-Sided | 95 | 3.3 | 12.5 | Percent of Participants | Superiority |
| PFS (%) at 12 months between treatments | Normal approximation | 0.6742 | Superiority |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
|
|
|
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
|
|
|
| Control (PLD or Topotecan) |
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual |
|
|
|
| Control (PLD or Topotecan) |
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual |
|
|
|
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual |
|
|
|