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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000902-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pimasertib (once daily) plus SAR245409 | Experimental |
| |
| Pimasertib (twice daily) plus SAR245409 placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimasertib once daily | Drug | Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response | Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (<) 10 millimeter (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 randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Augusta | Georgia | 30912 | United States | ||
| Research site |
Not provided
First/last participants (informed consent): Sep 2013/Oct 2014. Clinical data cut off: Jan 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimasertib (Once Daily) Plus SAR245409 | Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pimasertib placebo | Drug | Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
| SAR245409 placebo | Drug | Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
| SAR245409 | Drug | SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
| Pimasertib twice daily | Drug | Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
| Time from randomization until first observation of progressive disease or death, assessed up to 52 months |
| Percentage of Participants With Disease Control | Disease control as per RECIST v.1.1 was defined as the proportion of participants with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. | Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months |
| Overall Survival | Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants. | Time from randomization until death, assessed up to 52 months |
| Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Baseline up to disease progression or withdrawal, assessed up to 52 months |
| Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28) | EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life. | Baseline up to disease progression or withdrawal, assessed up to 52 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death | TEAEs, Serious TEAEs and AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious Adverse Event was 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. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state. | First dose of study drug up to 52 months |
| Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409 | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 |
| Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409 | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 |
| Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood | Screening visit (day -28 to 1) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Research site | Indianapolis | Indiana | 46202 | United States |
| Research site | Silver Spring | Maryland | 20910 | United States |
| Research site | Boston | Massachusetts | 02114 | United States |
| Research site | Boston | Massachusetts | 02215-5450 | United States |
| Research site | Ann Arbor | Michigan | 48109 | United States |
| Research site | Detroit | Michigan | 48202 | United States |
| Research site | Kansas City | Missouri | 64111 | United States |
| Research site | St Louis | Missouri | 63110 | United States |
| Research site | Kalispell | Montana | 59901 | United States |
| Research site | New York | New York | 10065 | United States |
| Research site | Cincinnati | Ohio | 45219 | United States |
| Research site | Columbus | Ohio | 43210 | United States |
| Research site | Middletown | Ohio | 45042 | United States |
| Research site | Nashville | Tennessee | 37203 | United States |
| Research site | Houston | Texas | 77030 | United States |
| Research site | Northmead | New South Wales | 2152 | Australia |
| Research site | Greenslopes | Queensland | 4120 | Australia |
| Research site | Subiaco | Western Australia | 6008 | Australia |
| Research site | Kortrijk | 8500 | Belgium |
| Research site | Leuven | 3000 | Belgium |
| Research site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research site | Toronto | Ontario | M4N 3M5 | Canada |
| Research site | Montreal | Quebec | H2L 4M1 | Canada |
| Research site | Montreal | Quebec | H2W 1S6 | Canada |
| Research site | Québec | G1R 2J6 | Canada |
| Research site | Bordeaux | Gironde | 33076 | France |
| Research site | Chorzów | 41-500 | Poland |
| Research site | Palma Mallorca | Balearic Islands | 07198 | Spain |
| Research site | Madrid | 28033 | Spain |
| Research site | Madrid | 28046 | Spain |
| Research site | Seville | 41013 | Spain |
| Research site | Valencia | 46010 | Spain |
| FG001 |
| Pimasertib (Twice Daily) Plus SAR245409 Placebo |
Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| COMPLETED |
|
| NOT COMPLETED |
|
Intent-to Treat (ITT) analysis set included all participant who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pimasertib (Once Daily) Plus SAR245409 | Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| BG001 | Pimasertib (Twice Daily) Plus SAR245409 Placebo | Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
| 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 | Objective Tumor Response | Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT analysis set included all participants who had been randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley. | ITT analysis set included all participants who had been randomized. | Posted | Median | 95% Confidence Interval | months | Time from randomization until first observation of progressive disease or death, assessed up to 52 months |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control | Disease control as per RECIST v.1.1 was defined as the proportion of participants with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. | ITT analysis set included all participants who had been randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants. | ITT analysis set included all participants who had been randomized. | Posted | Count of Participants | Participants | Time from randomization until death, assessed up to 52 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued. | Posted | Baseline up to disease progression or withdrawal, assessed up to 52 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28) | EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life. | Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued. | Posted | Baseline up to disease progression or withdrawal, assessed up to 52 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death | TEAEs, Serious TEAEs and AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious Adverse Event was 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. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state. | Safety population (SAF) analysis set included all participants who received at least one dose of any trial treatment. | Posted | Count of Participants | Participants | First dose of study drug up to 52 months |
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409 | As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | Posted | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409 | As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | Posted | Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood | As per changed in planned analysis the outcome measure related to pharmacodynamics parameters was not assessed. | Posted | Screening visit (day -28 to 1) |
|
|
First dose of study drug up to 52 months
SAF included all participants who received at least 1 dose of any trial treatment. SAF for "Pimasertib (Once Daily) Plus SAR245409" = 32 participants and "Pimasertib (Twice Daily) Plus SAR245409 Placebo" = 32 participants. Adverse events analysis was based on the SAF which includes 64 participants but 1 participant was randomized by error and not treated therefore not adverse event analysis.
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 | Pimasertib (Once Daily) Plus SAR245409 | Participants received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. | 16 | 32 | 32 | 32 | ||
| EG001 | Pimasertib (Twice Daily) Plus SAR245409 Placebo | Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. | 18 | 32 | 32 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 20.1 | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Macular detachment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| 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 |
|---|---|
| C576808 | XL765 |
Not provided
Not provided
Not provided
| Male |
|
| OG001 |
| Pimasertib (Twice Daily) Plus SAR245409 Placebo |
Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
|
Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
|
|
|
| OG001 | Pimasertib (Twice Daily) Plus SAR245409 Placebo | Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
|
Participants received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. |
|
|