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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03184870
Registration number
NCT03184870
Ethics application status
Date submitted
9/06/2017
Date registered
14/06/2017
Date last updated
3/07/2023
Titles & IDs
Public title
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
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Scientific title
A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
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Secondary ID [1]
0
0
2017-001725-40
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Secondary ID [2]
0
0
CV202-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
0
0
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Pancreatic Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-813160
Treatment: Other - Nivolumab
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - 5-fluorouracil (5-FU)
Treatment: Drugs - Leucovorin
Treatment: Drugs - Irinotecan
Experimental: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI - FOLFIRI: FOL (folinic acid \[leucovorin\]) F (fluorouracil \[5-fluorouracil\]) IRI (irinotecan \[CAMPTOSAR\])
Experimental: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel -
Experimental: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab - 2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable
Experimental: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI -
Experimental: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI -
Experimental: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI -
Experimental: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel -
Experimental: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel -
Experimental: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel -
Experimental: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab -
Experimental: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab -
Experimental: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy -
Experimental: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy -
Treatment: Drugs: BMS-813160
Specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days
Treatment: Drugs: Gemcitabine
Specified dose on specified days
Treatment: Drugs: 5-fluorouracil (5-FU)
Specified dose on specified days
Treatment: Drugs: Leucovorin
Specified dose on specified days
Treatment: Drugs: Irinotecan
Specified dose on specified days
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Intervention code [1]
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0
Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Incidence of Adverse events (AEs)
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Assessment method [1]
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Part 1 only
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Timepoint [1]
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Approximately 4 years
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Primary outcome [2]
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0
Incidence of Serious adverse events (SAEs)
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Assessment method [2]
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0
Part 1 only
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Timepoint [2]
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0
Approximately 4 years
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Primary outcome [3]
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Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
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Assessment method [3]
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0
Part 1 only
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Timepoint [3]
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0
Approximately 6 months
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Primary outcome [4]
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0
Incidence of AEs leading to discontinuation
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Assessment method [4]
0
0
Part 1 only
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Timepoint [4]
0
0
Approximately 4 years
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Primary outcome [5]
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0
Incidence of Death
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Assessment method [5]
0
0
Part 1 only
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Timepoint [5]
0
0
Approximately 4 years
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Primary outcome [6]
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0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
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Assessment method [6]
0
0
Part 1 only
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Timepoint [6]
0
0
Approximately 4 years
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Primary outcome [7]
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0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
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Assessment method [7]
0
0
Part 1 only
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Timepoint [7]
0
0
Approximately 4 years
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Primary outcome [8]
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0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
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Assessment method [8]
0
0
Part 1 only
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Timepoint [8]
0
0
Approximately 4 years
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Primary outcome [9]
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0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
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Assessment method [9]
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Part 1 only PR interval: The time from the onset of the P wave to the start of the QRS complex
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Timepoint [9]
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0
Approximately 4 years
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Primary outcome [10]
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0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
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Assessment method [10]
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0
Part 1 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
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Timepoint [10]
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0
Approximately 4 years
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Primary outcome [11]
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0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
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Assessment method [11]
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Part 1 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave
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Timepoint [11]
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Approximately 4 years
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Primary outcome [12]
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0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
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Assessment method [12]
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Part 1 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
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Timepoint [12]
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Approximately 4 years
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Primary outcome [13]
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0
Incidence of clinically significant changes in vital signs: Body temperature
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Assessment method [13]
0
0
Part 1 only
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Timepoint [13]
0
0
Approximately 4 years
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Primary outcome [14]
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0
Incidence of clinically significant changes in vital signs: Respiratory rate
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Assessment method [14]
0
0
Part 1 only
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Timepoint [14]
0
0
Approximately 4 years
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Primary outcome [15]
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0
Incidence of clinically significant changes in vital signs: Pulse oximetry
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Assessment method [15]
0
0
Part 1 only
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Timepoint [15]
0
0
Approximately 4 years
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Primary outcome [16]
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0
Incidence of clinically significant changes in vital signs: Blood pressure
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Assessment method [16]
0
0
Part 1 only
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Timepoint [16]
0
0
Approximately 4 years
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Primary outcome [17]
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Incidence of clinically significant changes in vital signs: Heart rate
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Assessment method [17]
0
0
Part 1 only
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Timepoint [17]
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0
Approximately 4 years
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Primary outcome [18]
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0
Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples
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Assessment method [18]
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0
Part 1 only
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Timepoint [18]
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0
Approximately 4 years
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Primary outcome [19]
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Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Assessment method [19]
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0
Part 2 only
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Timepoint [19]
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Approximately 2 years
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Primary outcome [20]
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Median duration of response (DOR)
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Assessment method [20]
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0
Part 2 only
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Timepoint [20]
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0
Approximately 2 years
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Primary outcome [21]
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Progression free survival (PFS) rate
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Assessment method [21]
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0
Part 2 only
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Timepoint [21]
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0
At 24 weeks
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Secondary outcome [1]
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Overall response rate (ORR)
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Assessment method [1]
0
0
Part 1 only
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Timepoint [1]
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Approximately 2 years
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Secondary outcome [2]
0
0
Median duration of response (DOR)
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Assessment method [2]
0
0
Part 1 only
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Timepoint [2]
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Approximately 2 years
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Secondary outcome [3]
0
0
Progression free survival (PFS) rate
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Assessment method [3]
0
0
Part 1 only
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Timepoint [3]
0
0
At 24 weeks
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Secondary outcome [4]
0
0
Maximum observed plasma concentration (Cmax)
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Assessment method [4]
0
0
Part 1 only
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Timepoint [4]
0
0
Approximately 4 years
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Secondary outcome [5]
0
0
Time of maximum observed plasma concentration (Tmax)
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Assessment method [5]
0
0
Part 1 only
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Timepoint [5]
0
0
Approximately 4 years
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Secondary outcome [6]
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0
Trough observed plasma concentration (Ctrough)
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Assessment method [6]
0
0
Part 1 only
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Timepoint [6]
0
0
Approximately 4 years
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Secondary outcome [7]
0
0
Observed plasma concentration at 24 hours post dose (C24)
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Assessment method [7]
0
0
Part 1 only
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Timepoint [7]
0
0
Approximately 4 years
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Secondary outcome [8]
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0
Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)]
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Assessment method [8]
0
0
Part 1 only
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Timepoint [8]
0
0
Approximately 4 years
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Secondary outcome [9]
0
0
Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]
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Assessment method [9]
0
0
Part 1 only
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Timepoint [9]
0
0
Approximately 4 years
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Secondary outcome [10]
0
0
Apparent total body clearance (CLT/F)
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Assessment method [10]
0
0
Part 1 only
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Timepoint [10]
0
0
Approximately 4 years
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Secondary outcome [11]
0
0
Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI)
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Assessment method [11]
0
0
Part 1 only
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Timepoint [11]
0
0
Approximately 4 years
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Secondary outcome [12]
0
0
Renal clearance (CLR)
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Assessment method [12]
0
0
Part 1 only
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Timepoint [12]
0
0
Approximately 4 years
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Secondary outcome [13]
0
0
Percent urinary recovery over 24 hours corrected for molecular weight (%UR)
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Assessment method [13]
0
0
Part 1 only
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Timepoint [13]
0
0
Approximately 4 years
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Secondary outcome [14]
0
0
Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax)
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Assessment method [14]
0
0
Part 1 only
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Timepoint [14]
0
0
Approximately 4 years
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Secondary outcome [15]
0
0
Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)]
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Assessment method [15]
0
0
Part 1 only
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Timepoint [15]
0
0
Approximately 4 years
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Secondary outcome [16]
0
0
Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy
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Assessment method [16]
0
0
Part 1 only
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Timepoint [16]
0
0
Approximately 4 years
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Secondary outcome [17]
0
0
Incidence of Adverse events (AEs)
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Assessment method [17]
0
0
Part 2 only
Query!
Timepoint [17]
0
0
Approximately 4 years
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Secondary outcome [18]
0
0
Incidence of Serious adverse events (SAEs)
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Assessment method [18]
0
0
Part 2 only
Query!
Timepoint [18]
0
0
Approximately 4 years
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Secondary outcome [19]
0
0
Incidence of AEs leading to discontinuation
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Assessment method [19]
0
0
Part 2 only
Query!
Timepoint [19]
0
0
Approximately 4 years
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Secondary outcome [20]
0
0
Incidence of Death
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Assessment method [20]
0
0
Part 2 only
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Timepoint [20]
0
0
Approximately 4 years
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Secondary outcome [21]
0
0
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
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Assessment method [21]
0
0
Part 2 Cohort 3b only
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Timepoint [21]
0
0
Approximately 6 months
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Secondary outcome [22]
0
0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
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Assessment method [22]
0
0
Part 2 only
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Timepoint [22]
0
0
Approximately 4 years
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Secondary outcome [23]
0
0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
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Assessment method [23]
0
0
Part 2 only
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Timepoint [23]
0
0
Approximately 4 years
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Secondary outcome [24]
0
0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
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Assessment method [24]
0
0
Part 2 only
Query!
Timepoint [24]
0
0
Approximately 4 years
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Secondary outcome [25]
0
0
Incidence of clinically significant changes in vital signs: Body temperature
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Assessment method [25]
0
0
Part 2 only
Query!
Timepoint [25]
0
0
Approximately 4 years
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Secondary outcome [26]
0
0
Incidence of clinically significant changes in vital signs: Respiratory rate
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Assessment method [26]
0
0
Part 2 only
Query!
Timepoint [26]
0
0
Approximately 4 years
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Secondary outcome [27]
0
0
Incidence of clinically significant changes in vital signs: Pulse oximetry
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Assessment method [27]
0
0
Part 2 only
Query!
Timepoint [27]
0
0
Approximately 4 years
Query!
Secondary outcome [28]
0
0
Incidence of clinically significant changes in vital signs: Blood pressure
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Assessment method [28]
0
0
Part 2 only
Query!
Timepoint [28]
0
0
Approximately 4 years
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Secondary outcome [29]
0
0
Incidence of clinically significant changes in vital signs: Heart rate
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Assessment method [29]
0
0
Part 2 only
Query!
Timepoint [29]
0
0
Approximately 4 years
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Secondary outcome [30]
0
0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Query!
Assessment method [30]
0
0
Part 2 only PR interval: The time from the onset of the P wave to the start of the QRS complex
Query!
Timepoint [30]
0
0
Approximately 4 years
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Secondary outcome [31]
0
0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Query!
Assessment method [31]
0
0
Part 2 only QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Query!
Timepoint [31]
0
0
Approximately 4 years
Query!
Secondary outcome [32]
0
0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Query!
Assessment method [32]
0
0
Part 2 only QT interval: Measured from the beginning of the QRS complex to the end of the T wave
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Timepoint [32]
0
0
Approximately 4 years
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Secondary outcome [33]
0
0
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
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Assessment method [33]
0
0
Part 2 only QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
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Timepoint [33]
0
0
Approximately 4 years
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Secondary outcome [34]
0
0
Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples
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Assessment method [34]
0
0
Part 2 only
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Timepoint [34]
0
0
Approximately 4 years
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Must have metastatic colorectal or pancreatic cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of =1
* Ability to swallow pills or capsules
* Required to undergo mandatory pre and on-treatment biopsies
* Adequate marrow function
* Adequate other organ functions
* Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up
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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
* Histology other than adenocarcinoma (neuroendocrine or acinar cell)
* Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
* Active, known or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
* Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
* History of allergy to study treatments or any of its components of the study arm that participant is enrolling
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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
8/08/2017
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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
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Actual
14/06/2023
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Sample size
Target
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Accrual to date
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Final
332
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Local Institution - 0028 - Clayton
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Recruitment postcode(s) [1]
0
0
0 - Clayton
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Minnesota
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Mississippi
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New Jersey
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New York
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Country [14]
0
0
United States of America
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State/province [14]
0
0
North Carolina
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Ohio
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Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
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Country [17]
0
0
United States of America
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State/province [17]
0
0
South Carolina
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Tennessee
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Utah
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Virginia
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Country [21]
0
0
Belgium
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State/province [21]
0
0
Bruxelles
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Country [22]
0
0
Belgium
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State/province [22]
0
0
Edegem
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Country [23]
0
0
Belgium
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State/province [23]
0
0
Leuven
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Country [24]
0
0
Canada
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State/province [24]
0
0
Alberta
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Country [25]
0
0
Canada
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State/province [25]
0
0
Ontario
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Country [26]
0
0
Germany
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State/province [26]
0
0
Dresden
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Country [27]
0
0
Germany
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State/province [27]
0
0
Heidelberg
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Country [28]
0
0
Spain
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State/province [28]
0
0
Barcelona
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Country [29]
0
0
Spain
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State/province [29]
0
0
Madrid
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Country [30]
0
0
Spain
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State/province [30]
0
0
Majadahonda - Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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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 evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.
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Trial website
https://clinicaltrials.gov/study/NCT03184870
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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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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03184870
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