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| ID | Type | Description | Link |
|---|---|---|---|
| DOXILOVC3001 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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the study was terminated due to medication supply issue from current manufacturer
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The purpose of this study is to compare the effectiveness between CAELYX and topotecan hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy, who have received no more than one prior platinum-based regimen therapy.
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), comparative bridging study (a supplemental study which performs to provide data of effectiveness, safety, and dosage to compare two study medications in a new region). The study consists of 3 phases: screening phase (30 days before administration of study medication), treatment phase, and follow up phase (every 8 weeks for tumor assessment until disease progression or death, or until the study completion, whichever is earlier and every 3 months after disease progression for overall survival and for anti-tumor therapy for a minimum of 1 year). In the treatment phase, approximately 120 eligible participants will be categorized prospectively for platinum-sensitivity (sensitive versus refractory) and bulky disease (presence versus absence). Later on participants will be randomly assigned either to experimental arm (CAELYX: administer on Day 1 of each cycle) or control arm (topotecan HCl: administer on Day 1 to Day 5 of each cycle). Treatment will continue until disease progression occurs and may continue for at least 2 cycles after confirmed complete response (disappearance of all target lesions). On average, it is expected that participants will continue treatment for approximately 3 to 6 cycles in experimental arm (CAELYX) or 4 to 8 cycles in Control arm (topotecan HCl). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, echocardiogram (or multiple gated acquisition scans), vital signs, and physical examination which will be monitored throughout the study. The total duration of the study will be approximately 23 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAELYX | Experimental | Participants will receive CAELYX 50 mg per square meter intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing PK evaluation. |
|
| Topotecan hydrochloride (HCl) | Active Comparator | Participants will receive topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAELYX | Drug | CAELYX 50 mg per square meter will be administered intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing for PK evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression-free Survival Incidence at Week 24 | Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-free Survival | It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS. | 1 year after the last dose (24 weeks) administration |
| Number of Participants With Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| 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. |
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Out of 32 participants screened, 26 were randomized to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAELYX | Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. |
| FG001 | Topotecan Hydrocloride (HCl) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Topotecan HCl | Drug | Topotecan 1.25 mg per square meter per day will be administered, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle. |
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Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered. |
| Up to Week 24 |
| Time to Response | It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements). | Up to Week 24 |
| Duration of Response | It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause. | Up to 1 year of last dose (Week 24) administration |
| Health-related Quality of Life Assessment (HQL) | Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life. | Day 1 of each cycle of study medication and Week 4 after last dose of study medication |
| Number of Participants With Overall Survival | Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause. | Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier |
| Maximum Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Time to Reach the Maximum Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Area Under the Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Systemic Clearance of Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Apparent Volume of Distribution of Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
| Number of Participants With Adverse Events | An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. | Up to 30 days after the last dose of study medication |
| Changsha |
| China |
| Guangzhou | China |
| Jinan | China |
| Nanjing | China |
| Nanning | China |
| Wuhan | China |
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
| COMPLETED |
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| NOT COMPLETED |
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The modified intent-to-treat population included (mITT) included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CAELYX | Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. |
| BG001 | Topotecan Hydrocloride (HCl) | Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Number of Participants With Progression-free Survival Incidence at Week 24 | Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The modified intent-to-treat population included (mITT) included all randomized participants. | Posted | Number | participants | Week 24 |
|
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| |||||||||||||||||||||||||||||
| Secondary | Duration of Progression-free Survival | It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS. | The mITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | weeks | 1 year after the last dose (24 weeks) administration |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response | Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered. | The mITT population included all randomized participants. | Posted | Number | participants | Up to Week 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response | It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements). | The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response. | Posted | Median | Full Range | weeks | Up to Week 24 |
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| |||||||||||||||||||||||||||||
| Secondary | Duration of Response | It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause. | The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response. | Posted | Median | 95% Confidence Interval | weeks | Up to 1 year of last dose (Week 24) administration |
|
| |||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Assessment (HQL) | Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life. | Data was not collected for this outcome measure as the study was early terminated. | Posted | Day 1 of each cycle of study medication and Week 4 after last dose of study medication |
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Survival | Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause. | The mITT population included all randomized participants. | Posted | Number | participants | Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier |
|
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Reach the Maximum Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
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| Secondary | Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
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| Secondary | Systemic Clearance of Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
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| Secondary | Apparent Volume of Distribution of Plasma Concentration of CAELYX | Data was not collected for this outcome measure as the study was early terminated. | Posted | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
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| Secondary | Number of Participants With Adverse Events | An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. | Safety population included all randomized participants. | Posted | Number | participants | Up to 30 days after the last dose of study medication |
|
Up to 30 days after the last dose of study medication
Safety population included all randomized participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAELYX | Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. | 1 | 14 | 12 | 14 | ||
| EG001 | Topotecan Hydrocloride (HCl) | Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle. | 1 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 15.0. | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Leukocytosis | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Neutrophilia | Blood and lymphatic system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Lymphocyte percentage decreased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Platelet count increased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA Version 15.0. | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Infusion related reaction | Immune system disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 15.0. | Non-systematic Assessment |
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The study was terminated early as the total number of participants treated in this study was low and only descriptive analysis was used for efficacy and safety evaluation.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clin Development | Xian Janssen Pharmaceutical LTD | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Counts |
|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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