Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004807-42 | EudraCT Number |
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORAb-202 | Experimental |
| |
| Investigator's Choice Chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORAb-202 | Drug | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment | Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments [using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks) |
| Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | From first dose of study medication up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Medical Conditions
Physical and Laboratory Test Findings
Allergies and Adverse Drug Reactions
Other protocol-defined inclusion/exclusion criteria apply.
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0065 | Sacramento | California | 95817 | United States | ||
| Local Institution - 0025 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See plan description
See plan description
Enrollment was stopped and no participants were enrolled into Arm A (MORAb-202 at 33 mg/m^2)
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| ID | Title | Description |
|---|---|---|
| FG000 | MORAb-202 | Participants received MORAb-202 25 mg/m^2 every 3 weeks for up to 2 years |
| FG001 | Investigator's Choice (IC) Chemotherapy | Participants received Paclitaxel 80 mg/m^2 every week; OR Pegylated liposomal doxorubicin (PLD) 40 mg/m^2 every 4 weeks; OR Topotecan 4 mg/m^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m^2 Days 1 to 5 every 3 weeks for up to 2 years |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-Treatment |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2024 |
Not provided
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| Paclitaxel | Drug | Specified dose on specified days |
|
|
| Pegylated Liposomal Doxorubicin (PLD) | Drug | Specified dose on specified days |
|
|
| Topotecan | Drug | Specified dose on specified days |
|
|
| Number of Participants With Serious Adverse Events (SAEs) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| Number of Participants With AEs Leading to Discontinuation | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| Number of Participants With Treatment-Related AEs | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| Number of Participants With Treatment-Related SAEs | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| Number of Participants With AEs of Special Interest (AESIs) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| Number of Participants Who Died | Number of participants who died during the study. | From first dose of study medication until death due to any cause (up to 70 weeks) |
| Number of Participants With Grade 3-4 Laboratory Abnormalities | Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function. Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment | Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Clopper and Pearson estimates of duration of response | From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks) |
| Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment | Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response | From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks) |
| Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment | Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival | From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks) |
| San Francisco |
| California |
| 94109 |
| United States |
| Local Institution - 0078 | Whittier | California | 90602-3171 | United States |
| Local Institution - 0081 | South Bend | Indiana | 46601-1033 | United States |
| Local Institution - 0043 | Kansas City | Kansas | 66160 | United States |
| Local Institution - 0023 | Canton | Ohio | 44710-1702 | United States |
| Local Institution - 0061 | Columbus | Ohio | 43219 | United States |
| Local Institution - 0044 | Nashville | Tennessee | 37203-1625 | United States |
| Local Institution - 0082 | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 0042 | Spokane | Washington | 99204 | United States |
| Local Institution - 0016 | Sydney | New South Wales | 2065 | Australia |
| Local Institution - 0017 | Waratah | New South Wales | 2298 | Australia |
| Local Institution - 0031 | Chermside | Queensland | 4032 | Australia |
| Local Institution - 0015 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 0027 | Malvern | Victoria | 3144 | Australia |
| Local Institution - 0058 | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0032 | Leuven | VBR | 3000 | Belgium |
| Local Institution - 0013 | Namur | WNA | 5000 | Belgium |
| Local Institution - 0012 | Brussels | 1200 | Belgium |
| Local Institution - 0045 | Liège | 4000 | Belgium |
| Local Institution - 0030 | Santiago | RM | 8420323 | Chile |
| Local Institution - 0036 | Santiago | 7510032 | Chile |
| Local Institution - 0029 | Temuco | 4800827 | Chile |
| Local Institution - 0046 | Jerusaelm | JM | 9112001 | Israel |
| Local Institution - 0054 | Haifa | 31999 | Israel |
| Local Institution - 0080 | Jerusalem | 91031 | Israel |
| Local Institution - 0055 | Ramat Gan | 5265601 | Israel |
| Local Institution - 0048 | Tel Aviv | 64239 | Israel |
| Local Institution - 0003 | Bologna | BO | 40138 | Italy |
| Local Institution - 0011 | Milan | MI | 20132 | Italy |
| Local Institution - 0009 | Milan | MI | 20141 | Italy |
| Local Institution - 0010 | Roma | RM | 00168 | Italy |
| Local Institution - 0002 | Brescia | 25123 | Italy |
| Local Institution - 0018 | Akashi, Hyogo | 673-8558 | Japan |
| Local Institution - 0019 | Chūōku | 104-0045 | Japan |
| Local Institution - 0014 | Hidaka-shi | 350-1298 | Japan |
| Local Institution - 0004 | Kurume-Shi | 830-0011 | Japan |
| Local Institution - 0037 | Tokyo | 135-8550 | Japan |
| Local Institution - 0056 | Seoul | 03080 | South Korea |
| Local Institution - 0049 | Seoul | 03722 | South Korea |
| Local Institution - 0053 | Seoul | 5505 | South Korea |
| Local Institution - 0039 | Barcelona | B | 08035 | Spain |
| Local Institution - 0005 | Madrid | M | 28007 | Spain |
| Local Institution - 0001 | Madrid | M | 28041 | Spain |
| Local Institution - 0007 | Valencia | V | 46009 | Spain |
| Local Institution - 0006 | Valencia | V | 46010 | Spain |
| Local Institution - 0021 | Barcelona | 08036 | Spain |
| Local Institution - 0020 | Girona | 17007 | Spain |
| Local Institution - 0038 | Madrid | 28033 | Spain |
| Local Institution - 0022 | Madrid | 28046 | Spain |
|
| COMPLETED | Completed = Treated |
|
| NOT COMPLETED |
|
| Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MORAb-202 | Participants received MORAb-202 25 mg/m^2 every 3 weeks for up to 2 years |
| BG001 | Investigator's Choice (IC) Chemotherapy | Participants received Paclitaxel 80 mg/m^2 every week; OR Pegylated liposomal doxorubicin (PLD) 40 mg/m^2 every 4 weeks; OR Topotecan 4 mg/m^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m^2 Days 1 to 5 every 3 weeks for up to 2 years |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment | Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments [using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All randomized participants | Posted | Number | 95% Confidence Interval | Percent of participants | From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | All treated participants | Posted | Count of Participants | Participants | From first dose of study medication up to 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs Leading to Discontinuation | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Related AEs | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Related SAEs | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs of Special Interest (AESIs) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died | Number of participants who died during the study. | All treated participants | Posted | Count of Participants | Participants | From first dose of study medication until death due to any cause (up to 70 weeks) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3-4 Laboratory Abnormalities | Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function. Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. | All treated participants | Posted | Count of Participants | Participants | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment | Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Clopper and Pearson estimates of duration of response | All randomized participants | Posted | Number | 95% Confidence Interval | Percent of participants | From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment | Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response | All confirmed responders | Posted | Median | 95% Confidence Interval | Months | From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment | Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks) |
|
Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
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 | MORAb-202 | Participants received MORAb-202 25 mg/m^2 every 3 weeks for up to 2 years | 34 | 70 | 22 | 70 | 61 | 70 |
| EG001 | Investigator's Choice (IC) Chemotherapy | Participants received Paclitaxel 80 mg/m^2 every week; OR Pegylated liposomal doxorubicin (PLD) 40 mg/m^2 every 4 weeks; OR Topotecan 4 mg/m^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m^2 Days 1 to 5 every 3 weeks for up to 2 years | 18 | 36 | 11 | 34 | 31 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.1 | Systematic Assessment |
| |
| Pain | General disorders | 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | 27.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 27.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | 27.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 27.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 27.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | 27.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Jun 12, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| 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 |
| D005184 | Fallopian Tube Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718069 | MORAb-202 |
| D017239 | Paclitaxel |
| C506643 | liposomal doxorubicin |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Other Reasons |
|
| Progressive Disease |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Participants received Paclitaxel 80 mg/m^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m^2 every 4 weeks; OR
Topotecan 4 mg/m^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m^2 Days 1 to 5 every 3 weeks for up to 2 years
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|