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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04251533
Registration number
NCT04251533
Ethics application status
Date submitted
30/01/2020
Date registered
5/02/2020
Date last updated
28/02/2024
Titles & IDs
Public title
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
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Scientific title
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation
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Secondary ID [1]
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2019-002637-11
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Secondary ID [2]
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CBYL719H12301
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Universal Trial Number (UTN)
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Trial acronym
EPIK-B3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - alpelisib
Treatment: Drugs - placebo
Treatment: Drugs - nab-paclitaxel
Experimental: alpelisib + nab-paclitaxel - Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Single arm Open label in Study Part B1
Placebo Comparator: placebo + nab-paclitaxel - Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Not applicable in Study Part B1
Treatment: Drugs: alpelisib
300 mg orally once per day (QD)
Treatment: Drugs: placebo
300 mg orally once per day (QD)
Treatment: Drugs: nab-paclitaxel
100 mg/m² as IV infusion on Days 1, 8 and 15 of a 28-day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
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Assessment method [1]
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PFS, defined as time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1
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Timepoint [1]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Primary outcome [2]
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Progression-free Survival (PFS) Per Investigator Assessment in Study Part B2
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Assessment method [2]
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PFS, defined as time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1
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Timepoint [2]
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Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months
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Primary outcome [3]
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Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in Study Part B1
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Assessment method [3]
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ORR is defined as the proportion of subjects with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1
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Timepoint [3]
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Up to 6 months
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Secondary outcome [1]
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Overall Survival (OS) in Study Part A
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Assessment method [1]
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OS is defined as the time from date of randomization to date of death due to any cause
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Timepoint [1]
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Up to 66 months
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Secondary outcome [2]
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Overall Survival (OS) in Study Part B2
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Assessment method [2]
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OS is defined as the time from date of randomization to date of death due to any cause
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Timepoint [2]
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Up to 41 months
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Secondary outcome [3]
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Overall response rate (ORR) with confirmed response in Study Part A
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Assessment method [3]
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ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1
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Timepoint [3]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [4]
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Overall response rate (ORR) with confirmed response in Study Part B2
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Assessment method [4]
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ORR with confirmed response is the proportion of subjects with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1
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Timepoint [4]
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Up to 22 months
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Secondary outcome [5]
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Clinical benefit rate (CBR) with confirmed response in Study Part A
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Assessment method [5]
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Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1
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Timepoint [5]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [6]
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Clinical benefit rate (CBR) with confirmed response in Study Part B1
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Assessment method [6]
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Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1
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Timepoint [6]
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0
Up to 6 months
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Secondary outcome [7]
0
0
Clinical benefit rate (CBR) with confirmed response in Study Part B2
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Assessment method [7]
0
0
Clinical benefit rate (CBR) with confirmed response is defined as the proportion of subjects with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1
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Timepoint [7]
0
0
Up to 22 months
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Secondary outcome [8]
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Time to response (TTR) in Study Part A
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Assessment method [8]
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Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1
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Timepoint [8]
0
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [9]
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Time to response (TTR) in Study Part B1
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Assessment method [9]
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Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1
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Timepoint [9]
0
0
Up to 6 months
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Secondary outcome [10]
0
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Time to response (TTR) in Study Part B2
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Assessment method [10]
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Time to response (TTR) is defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review and according to RECIST 1.1
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Timepoint [10]
0
0
Up to 22 months
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Secondary outcome [11]
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Duration of Response (DOR) with confirmed response in Study Part A
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Assessment method [11]
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Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer
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Timepoint [11]
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0
Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [12]
0
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Duration of Response (DOR) with confirmed response in Study Part B1
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Assessment method [12]
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Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer
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Timepoint [12]
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Up to 6 months
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Secondary outcome [13]
0
0
Duration of Response (DOR) with confirmed response in Study Part B2
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Assessment method [13]
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Duration of response (DOR) with confirmed response only applies to subjects whose best overall response is confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer
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Timepoint [13]
0
0
Up to 22 months
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Secondary outcome [14]
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Overall Survival (OS) in Study Part B1
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Assessment method [14]
0
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OS is defined as the time from date of enrolment to date of death due to any cause
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Timepoint [14]
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Up to 6 months
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Secondary outcome [15]
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Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1
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Assessment method [15]
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PFS, defined as time from the date of enrolment to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1
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Timepoint [15]
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Up to 6 months
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Secondary outcome [16]
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Plasma concentrations of alpelisib in Study Part B2
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Assessment method [16]
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Summary statistics of plasma alpelisib concentrations by time point
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Timepoint [16]
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up to 22 months
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Secondary outcome [17]
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Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in Study Part B2
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Assessment method [17]
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Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment
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Timepoint [17]
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Up to 22 months
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Secondary outcome [18]
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Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in Study Part B2
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Assessment method [18]
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Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items & is composed of both multi-item scales & single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items & a global health status/QoL scale. The scales & single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A 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
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Timepoint [18]
0
0
Up to 22 months
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Secondary outcome [19]
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PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in Study Part A
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Assessment method [19]
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PFS in patients with PIK3CA mutation as measured in ctDNA
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Timepoint [19]
0
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [20]
0
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PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in Study Part B2
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Assessment method [20]
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PFS in patients with PIK3CA mutation as measured in ctDNA
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Timepoint [20]
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Up to 22 months
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Secondary outcome [21]
0
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Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2
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Assessment method [21]
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Definitive deterioration of ECOG PS is defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause
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Timepoint [21]
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Up to 22 months
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Eligibility
Key inclusion criteria
- Participant has histologically confirmed diagnosis of advanced (loco-regionally
recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC
- Participant has either a measurable disease per RECIST 1.1 criteria or, if no
measurable disease is present, then at least one predominantly lytic bone lesion or
mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be
evaluated by CT/MRI) must be present Part B1: Participants must have measurable
disease
- Participant has adequate tumor tissue to identify the PIK3CA mutation status (either
carrying a mutation or without a mutation) and the PTEN loss status; both of which
will determine whether the subject can be allocated to Part A - PIK3CA mutation
regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without
a PIK3CA mutation
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1
- Participant has received no more than one line of therapy for metastatic disease
- Participant has adequate bone marrow and organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
- Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of
their excipients
- Participant has not recovered from all toxicities related to prior anticancer
therapies to NCI CTCAE version 4.03 Grade =1; with the exception of alopecia
- Participant has central nervous system (CNS) involvement which was not previously
treated and/or was newly detected at screening
- Participant with an established diagnosis of diabetes mellitus type I or uncontrolled
type II based on Fasting Plasma Glucose and HbA1c
- Participant has impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of the study drugs (e.g., ulcerative diseases,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel
resection) based on investigator discretion
- Participant has a history of acute pancreatitis within 1 year prior to screening or
past medical history of chronic pancreatitis
- Participant has currently documented pneumonitis/interstitial lung disease
- Participant has a history of severe cutaneous reactions, such as Steven-Johnson
Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug
Reaction with Eosinophilia and Systemic Syndrome (DRESS)
- Participant with unresolved osteonecrosis of the jaw
Other protocol-defined inclusion/exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
137
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Melbourne
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Recruitment hospital [2]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
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California
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Country [2]
0
0
United States of America
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State/province [2]
0
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Louisiana
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Country [3]
0
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United States of America
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State/province [3]
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Minnesota
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Country [4]
0
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United States of America
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State/province [4]
0
0
Tennessee
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Country [5]
0
0
Argentina
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State/province [5]
0
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Buenos Aires
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Country [6]
0
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Argentina
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State/province [6]
0
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Santa Fe
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Country [7]
0
0
Austria
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State/province [7]
0
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Tyrol
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Country [8]
0
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Austria
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State/province [8]
0
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Leoben
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Country [9]
0
0
Brazil
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State/province [9]
0
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SP
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Country [10]
0
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Bulgaria
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State/province [10]
0
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Plovdiv
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Country [11]
0
0
China
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State/province [11]
0
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Anhui
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Country [12]
0
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China
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State/province [12]
0
0
Hebei
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Country [13]
0
0
China
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State/province [13]
0
0
Hunan
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Country [14]
0
0
China
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State/province [14]
0
0
Jiangsu
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Country [15]
0
0
China
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State/province [15]
0
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Jilin
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Country [16]
0
0
China
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State/province [16]
0
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Liaoning
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Country [17]
0
0
China
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State/province [17]
0
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Sichuan
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Country [18]
0
0
China
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State/province [18]
0
0
Zhejiang
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Country [19]
0
0
China
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State/province [19]
0
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Dalian
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Country [20]
0
0
China
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State/province [20]
0
0
Shanghai
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Country [21]
0
0
China
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State/province [21]
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Shenyang
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Country [22]
0
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China
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State/province [22]
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Tianjin
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Country [23]
0
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Colombia
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State/province [23]
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Bogota
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Country [24]
0
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Croatia
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State/province [24]
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Zagreb
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Country [25]
0
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France
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State/province [25]
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Hauts De Seine
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Country [26]
0
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France
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State/province [26]
0
0
Angers Cedex 02
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Country [27]
0
0
France
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State/province [27]
0
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Saint-Herblain Cédex
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Country [28]
0
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France
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State/province [28]
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0
Villejuif
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Country [29]
0
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Germany
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State/province [29]
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Dresden
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Country [30]
0
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Germany
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State/province [30]
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Essen
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0
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Germany
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State/province [31]
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Leipzig
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Hungary
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State/province [32]
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Budapest
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0
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India
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State/province [33]
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Haryana
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Country [34]
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India
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Maharashtra
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India
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Tamil Nadu
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India
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Telangana
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Israel
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Tel Aviv
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Italy
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FC
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Italy
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RM
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Italy
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Napoli
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Korea, Republic of
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Seoul
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Malaysia
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Selangor
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Malaysia
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Kuala Lumpur
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Mexico
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Nuevo Leon
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Norway
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Oslo
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Peru
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La Libertad
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Poland
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Gdynia
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Poland
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Opole
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Poland
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Poznan
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Pushkin Saint Petersburg
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0
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Slovakia
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Slovak Republic
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Slovakia
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Bratislava
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Slovakia
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State/province [56]
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Kosice
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0
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Slovenia
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Ljubljana
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0
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South Africa
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0
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Western Cape
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Country [59]
0
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South Africa
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State/province [59]
0
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Johannesburg
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0
0
Spain
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0
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Comunidad Valenciana
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Spain
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State/province [61]
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Extremadura
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Country [62]
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Spain
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State/province [62]
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Islas Baleares
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Country [63]
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Switzerland
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State/province [63]
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Lausanne
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Country [64]
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Taiwan
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State/province [64]
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Taipei
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Country [65]
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Turkey
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State/province [65]
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Istanbul
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Country [66]
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United Kingdom
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State/province [66]
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Nottingham
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Country [67]
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United Kingdom
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State/province [67]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether treatment with alpelisib in combination
with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast
cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study
Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04251533
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04251533
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