Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001962-27 | EudraCT Number | ||
| U1111-1182-7044 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Study discontinued considering the limited clinical benefit combined with a higher than expected rate of known non-serious ophthalmological event.
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Primary Objective:
To evaluate the tumor Objective Response Rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of SAR566658 in participants with anti-carbonic anhydrase 6 (CA6)-positive metastatic triple negative breast cancer (TNBC). Part 1: To select the SAR566658 dose based on ORR and safety of 2 dose levels of SAR566658. Part 2: Part 2a: To demonstrate the activity of SAR566658 based on ORR in participants overexpressing CA6 (membrane intensity of 2+, 3+ in greater than or equal to (>=) 30% of tumor cells) treated at the selected dose in an expanded cohort, in addition to the participants treated in Part 1. - Part 2b: To assess the efficacy in participants with metastatic TNBC and mild CA6 expression.
Secondary Objectives:
To assess:
The duration of the study for 1 participant included a screening period of up to 21 days prior to first study drug administration, 3-week treatment cycle(s) (until 30 days after last SAR566658 administration), and a follow-up period. Each participant was treated until radiological disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR566658 90 mg/m^2 | Experimental | Participants received SAR566658 90 milligram per square meter (mg/m^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). |
|
| SAR566658 120 mg/m^2 | Experimental | Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR566658 (ACT14884) | Drug | Pharmaceutical form:Solution Route of administration: Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings | Predefined safety criteria was defined as occurrence of following IMP-related treatment-emergent adverse event (TEAE) (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03): Grade greater than or equal to (>=) 3 TEAE from the System Organ Class (SOC) of eye disorders, Grade >=3 peripheral neuropathy (Preferred Term), Grade >=4 TEAE. Per NCI-CTCAE v4.03, Adverse Events (AE) were graded as follows: Grade 1: Mild; asymptomatic/mild symptoms; Grade 2: Moderate; minimal, local or non-invasive intervention indicated; Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. | Up to Cycle 2 (each cycle of 21 days) |
| Percentage of Participants With Objective Response | Objective Response in participants was defined as the participants with complete response (CR) and partial response (PR) as best response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). As per RECIST 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Control | Disease control in participants was defined as the participants with CR, PR and stable disease (SD) with a duration of at least 3 months. As per RECIST 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study. |
Not provided
Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 0560001 | Leuven | 3000 | Belgium | |||
| Investigational Site Number 2030002 |
A total of 23 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study and included in Part 1. The study was prematurely terminated due to safety reasons, hence Part 2 was not conducted and no analysis was performed.
The study was conducted at 13 sites in 5 countries from 23 March 2017 to 07 September 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SAR566658 90 mg/m^2 | Participants received SAR566658 90 milligram per square meter (mg/m^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). |
| FG001 | SAR566658 120 mg/m^2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2016 | Aug 9, 2021 |
Not provided
Not provided
Not provided
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Not provided
| Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| Duration of Response (DOR) | DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first radiological documentation of tumor progression or death (due to any cause), whichever comes first. As per RECIST 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| Progression Free Survival (PFS) | PFS was defined as the time interval between the date of first study treatment administration and the date of documented tumor progression or death (due to any cause), whichever comes first. As per RECIST 1.1, progression was defined as at least a 20% increase in the sum of diameters of target lesions. | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| Time to Tumor Progression (TTP) | TTP was defined as the time interval between the date of first study treatment administration and the date of the first radiologically documented tumor progression. As per RECIST 1.1, progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (SAE) | AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during the on-treatment period (the time from the first treatment administration to the last treatment administration +30 days). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. | Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days) |
| Number of Participants With Keratopathies (Corneal Toxicity) | Keratopathy is an eye disorder that involves a blister-like swelling of the cornea (the clear layer in front of the iris and pupil). All participants received ocular primary prophylaxis in each eye in order to prevent the occurrence of keratopathies at the time of each infusion (vasoconstrictor, ophthalmic topical steroid, and cold mask on eyes) and steroid eye drops for an additional 2 days following SAR566658 administration. | Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days) |
| Number of Participants With Positive Anti-SAR566658 Antibodies Response | Up to 3 treatment cycles, each cycle 21 days |
| Prague |
| 12808 |
| Czechia |
| Investigational Site Number 3800003 | Genova | 16132 | Italy |
| Investigational Site Number 3800001 | Milan | 20132 | Italy |
| Investigational Site Number 3800004 | Roma | 00144 | Italy |
| Investigational Site Number 5280001 | Maastricht | 6229 HX | Netherlands |
| Investigational Site Number 5280002 | Rotterdam | 3015 GD | Netherlands |
| Investigational Site Number 7240002 | Barcelona | 08035 | Spain |
| Investigational Site Number 7240005 | Lleida | 25198 | Spain |
| Investigational Site Number 7240001 | Madrid | 28034 | Spain |
| Investigational Site Number 7240006 | Madrid | 28041 | Spain |
| Investigational Site Number 7240003 | Seville | 41013 | Spain |
| Investigational Site Number 7240004 | Valencia | 46010 | Spain |
Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on randomized population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SAR566658 90 mg/m^2 | Participants received SAR566658 90 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). |
| BG001 | SAR566658 120 mg/m^2 | Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). |
| 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 |
| ||||||||||||||||
| 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 | Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings | Predefined safety criteria was defined as occurrence of following IMP-related treatment-emergent adverse event (TEAE) (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03): Grade greater than or equal to (>=) 3 TEAE from the System Organ Class (SOC) of eye disorders, Grade >=3 peripheral neuropathy (Preferred Term), Grade >=4 TEAE. Per NCI-CTCAE v4.03, Adverse Events (AE) were graded as follows: Grade 1: Mild; asymptomatic/mild symptoms; Grade 2: Moderate; minimal, local or non-invasive intervention indicated; Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. | Analysis was performed on participants evaluable for predefined safety criteria population which included participants treated in the study and had completed 2 cycles, or who experienced predefined safety criteria. | Posted | Count of Participants | Participants | Up to Cycle 2 (each cycle of 21 days) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Objective Response | Objective Response in participants was defined as the participants with complete response (CR) and partial response (PR) as best response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). As per RECIST 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Analysis was performed on all-treated population which included participants who actually received at least 1 dose or any partial dose of SAR566658. | Posted | Number | 80% Confidence Interval | percentage of participants | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control | Disease control in participants was defined as the participants with CR, PR and stable disease (SD) with a duration of at least 3 months. As per RECIST 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study. | Data for this outcome measure was not collected and analyzed due to early termination of the study. | Posted | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first radiological documentation of tumor progression or death (due to any cause), whichever comes first. As per RECIST 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. | Data for this outcome measure was not collected and analyzed due to early termination of the study. | Posted | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time interval between the date of first study treatment administration and the date of documented tumor progression or death (due to any cause), whichever comes first. As per RECIST 1.1, progression was defined as at least a 20% increase in the sum of diameters of target lesions. | Data for this outcome measure was not collected and analyzed due to early termination of the study. | Posted | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time interval between the date of first study treatment administration and the date of the first radiologically documented tumor progression. As per RECIST 1.1, progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Data for this outcome measure was not collected and analyzed due to early termination of the study. | Posted | Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (SAE) | AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during the on-treatment period (the time from the first treatment administration to the last treatment administration +30 days). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. | Analysis was performed on all treated population. | Posted | Count of Participants | Participants | Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Keratopathies (Corneal Toxicity) | Keratopathy is an eye disorder that involves a blister-like swelling of the cornea (the clear layer in front of the iris and pupil). All participants received ocular primary prophylaxis in each eye in order to prevent the occurrence of keratopathies at the time of each infusion (vasoconstrictor, ophthalmic topical steroid, and cold mask on eyes) and steroid eye drops for an additional 2 days following SAR566658 administration. | Analysis was performed on all treated population. | Posted | Count of Participants | Participants | No | Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-SAR566658 Antibodies Response | Data for this outcome measure was not collected and analyzed due to early termination of the study. | Posted | Up to 3 treatment cycles, each cycle 21 days |
|
|
Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days.
Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
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 | SAR566658 90 mg/m^2 | Participants received SAR566658 90 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). | 0 | 11 | 1 | 11 | 11 | 11 |
| EG001 | SAR566658 120 mg/m^2 | Participants received SAR566658 120 mg/m^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3). | 0 | 12 | 6 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Metastases To Meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear Pruritus | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abnormal Sensation In Eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Corneal Epithelial Microcysts | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Corneal Opacity | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Halo Vision | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Device Related Thrombosis | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Breast Ulceration | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
The study was prematurely discontinued considering the limited clinical benefit combined with higher than expected rate of known non-serious ophthalmological event, hence Part 2 was not conducted and some of pre-specified endpoints were not analyzed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | option 6 | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2018 | Aug 9, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717733 | SAR-566658 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade>=4 related TEAE |
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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