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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03911869




Registration number
NCT03911869
Ethics application status
Date submitted
14/03/2019
Date registered
11/04/2019

Titles & IDs
Public title
An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
Scientific title
A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis
Secondary ID [1] 0 0
C4221006
Secondary ID [2] 0 0
ARRAY-818-201
Universal Trial Number (UTN)
Trial acronym
POLARIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - encorafenib
Treatment: Drugs - binimetinib

Experimental: Standard Dose Arm - Patients in the standard-dose treatment arm will receive encorafenib and binimetinib in 28-day cycles.

* 450 mg encorafenib orally once a day (QD)
* 45 mg binimetinib orally twice a day (BID)

Patients who are able to tolerate the standard dose during the first 4 weeks of treatment (Cycle 1) should be dose-escalated to 600 mg encorafenib QD plus 45 mg binimetinib BID provided they meet protocol-defined criteria.

Experimental: High Dose Arm - Patients in the high-dose treatment arm will receive encorafenib and binimetinib in 28-day cycles.

* 300 mg encorafenib orally twice a day (BID)
* 45 mg binimetinib orally twice a day (BID)


Treatment: Drugs: encorafenib
taken orally

Treatment: Drugs: binimetinib
taken orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs): Safety Lead-in (SLI) Phase
Timepoint [1] 0 0
Cycle 1 of SLI phase (up to 28 days)
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI _CTCAE) Version (v) 4.03: SLI Phase
Timepoint [2] 0 0
Day 1 of dosing up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [3] 0 0
Number of Participants With Hepatology Laboratory Test Abnormalities: SLI Phase
Timepoint [3] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [4] 0 0
Number of Participants With Shift From Baseline for Hematology and Coagulation Laboratory Test Abnormalities Based on NCI-CTCAE v4.03: SLI Phase
Timepoint [4] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [5] 0 0
Number of Participants With Shift From Baseline for Biochemistry Laboratory Test Abnormalities Based on NCI-CTCAE v4.03: SLI Phase
Timepoint [5] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [6] 0 0
Number of Participants With Notable Abnormal Vital Signs: SLI Phase
Timepoint [6] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [7] 0 0
Number of Participants With Notable Abnormal Electrocardiogram (ECG) Values: SLI Phase
Timepoint [7] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [8] 0 0
Number of Participants With Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to AEs: SLI Phase
Timepoint [8] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in SLI Phase, maximum duration up to 10.4 months
Primary outcome [9] 0 0
Brain Metastasis Response Rate (BMRR) Based on Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (mRECIST v1.1): Phase 2
Timepoint [9] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in Phase 2 (approximately up to 8.3 months)
Secondary outcome [1] 0 0
Extracranial Response Rate Based on RECIST v1.1: SLI Phase and Phase 2
Timepoint [1] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [2] 0 0
Global Response Rate: SLI Phase and Phase 2
Timepoint [2] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [3] 0 0
Disease Control Rate (DCR) for Brain Metastasis Response Based on mRECIST v1.1: SLI Phase and Phase 2
Timepoint [3] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [4] 0 0
DCR for Extracranial Response Based on RECIST v1.1: SLI Phase and Phase 2
Timepoint [4] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [5] 0 0
DCR for Global Response: SLI Phase and Phase 2
Timepoint [5] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [6] 0 0
Duration of Response (DOR) for Brain Metastasis Response Based on mRECIST v1.1: SLI Phase and Phase 2
Timepoint [6] 0 0
From date of first radiographic response (CR or PR) to earliest documented disease progression or death due to any cause in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [7] 0 0
DOR for Global Response: SLI Phase and Phase 2
Timepoint [7] 0 0
From date of first radiographic response (CR or PR) to earliest documented disease progression or death due to any cause in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [8] 0 0
DOR for Extracranial Response Based on RECIST v1.1: SLI Phase and Phase 2
Timepoint [8] 0 0
From date of first radiographic response (CR or PR) to earliest documented disease progression or death due to any cause in SLI Phase (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [9] 0 0
Progression Free Survival (PFS) for Brain Metastasis Based on mRECIST v1.1: SLI Phase and Phase 2
Timepoint [9] 0 0
From date of first dose of study treatment to the earliest documented disease progression by investigator assessment, or death due to any cause, whichever occurs first in SLI (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [10] 0 0
PFS for Global Tumor Assessment: SLI Phase and Phase 2
Timepoint [10] 0 0
From date of first dose of study treatment to the earliest documented disease progression by investigator assessment, or death due to any cause, whichever occurs first in SLI (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [11] 0 0
BMRR Based on mRECIST v1.1: SLI Phase
Timepoint [11] 0 0
From date of first dose until disease progression, death due to any cause or subsequent therapy initiation, whichever occurred first in SLI Phase (approximately up to 10.4 months)
Secondary outcome [12] 0 0
Overall Survival: SLI Phase and Phase 2
Timepoint [12] 0 0
From date of first dose of study treatment to the earliest documented disease progression by investigator assessment, or death due to any cause, whichever occurs first in SLI (approximately up to 10.4 months) and Phase 2 (approximately up to 8.3 months)
Secondary outcome [13] 0 0
Number of Participants With Treatment Emergent AEs of Maximum Severity Grades Based on NCI CTCAE v4.03: Phase 2
Timepoint [13] 0 0
Day 1 of dosing up to 30 days after last dose of study drug in Phase 2, maximum duration up to 8.3 months
Secondary outcome [14] 0 0
Number of Participants With Hepatology Laboratory Test Abnormalities: Phase 2
Timepoint [14] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in Phase 2, maximum duration up to 8.3 months
Secondary outcome [15] 0 0
Number of Participants With Shift From Baseline for Hematology and Coagulation Laboratory Test Abnormalities Based on NCI-CTCAE v4.03: Phase 2
Timepoint [15] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in Phase 2, maximum duration up to 8.3 months
Secondary outcome [16] 0 0
Number of Participants With Shift From Baseline for Biochemistry Laboratory Test Abnormalities Based on NCI-CTCAE v4.03: Phase 2
Timepoint [16] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in Phase 2, maximum duration up to 8.3 months
Secondary outcome [17] 0 0
Number of Participants With Clinically Significant Change in Notable Abnormal Vital Signs: Phase 2
Timepoint [17] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in Phase 2, maximum duration up to 8.3 months
Secondary outcome [18] 0 0
Number of Participants With Notable Abnormal Electrocardiogram (ECG) Values: Phase 2
Timepoint [18] 0 0
Baseline (Day 1) up to 30 days after last dose of study drug in Phase 2, maximum duration up to 8.3 months
Secondary outcome [19] 0 0
Plasma Concentrations of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [19] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose; Pre-dose on Cycle 2 Day 1, Cycle 3 Day 1
Secondary outcome [20] 0 0
Plasma Concentrations of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [20] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose; Pre-dose on Cycle 2 Day 1, Cycle 3 Day 1
Secondary outcome [21] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 6 Hours (AUC 0-6) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [21] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [22] 0 0
AUC0-6 of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [22] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [23] 0 0
Area Under the Plasma Concentration-time Curve From Time Zero to Last Time Point (AUClast) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [23] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [24] 0 0
AUClast of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [24] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [25] 0 0
Area Under the Plasma Concentration-time Curve From Time Zero to Tau (AUCtau) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [25] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [26] 0 0
AUCtau of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [26] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [27] 0 0
Maximum Observed Plasma Concentration (Cmax) After Drug Administration of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [27] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [28] 0 0
Cmax of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [28] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [29] 0 0
Minimum Observed Plasma Concentration (Cmin) at the End of a Dosing Interval at Steady State of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [29] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [30] 0 0
Cmin of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [30] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [31] 0 0
Ctrough of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [31] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose; Pre-dose on Cycle 2 Day 1, Cycle 3 Day 1
Secondary outcome [32] 0 0
Ctrough of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [32] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose; Pre-dose on Cycle 2 Day 1, Cycle 3 Day 1
Secondary outcome [33] 0 0
Time to Reach Maximum Concentration (Tmax) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [33] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [34] 0 0
Tmax of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [34] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hrs (+/- 20 minutes [min]) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs (+/- 20 min) post-dose
Secondary outcome [35] 0 0
Time of Last PK Sample (Tlast) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [35] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6, 24 hrs post-dose
Secondary outcome [36] 0 0
Tlast of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [36] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6, 12 hrs post-dose
Secondary outcome [37] 0 0
Accumulation Ratio Between AUClast,ss and AUClast (RAUC) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [37] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [38] 0 0
RAUC of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [38] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [39] 0 0
Accumulation Ratio Between Cmax,ss and Cmax (RCmax) of Encorafenib and Its Metabolite LHY746: SLI Phase
Timepoint [39] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [40] 0 0
Rcmax of Binimetinib and Its Metabolite AR00426032: SLI Phase
Timepoint [40] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [41] 0 0
Ratio of AUClast Values of the Metabolite Compared to Parent (MRAUClast) of LHY746: SLI Phase
Timepoint [41] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [42] 0 0
MRAUClast of AR00426032: SLI Phase
Timepoint [42] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [43] 0 0
Ratio of Cmax Values of the Metabolite Compared to Parent (MRCmax) of LHY746: SLI Phase
Timepoint [43] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose
Secondary outcome [44] 0 0
MRCmax of AR00426032: SLI Phase
Timepoint [44] 0 0
Cycle 1 Day 1: 0.5, 1.5, 3, 6 hours (hrs) post-dose; Cycle 1 Day 15: Pre-dose, 0.5, 1.5, 3, 6 hrs post-dose

Eligibility
Key inclusion criteria
Key

* Histologically confirmed diagnosis of cutaneous melanoma with metastases to the brain.
* Presence of B-RAF proto-oncogene, V600 mutant (BRAFV600) mutation in tumor tissue previously determined by a local PCR or NGS-based assay at any time prior to Screening or by a central laboratory during Screening.
* Must have at least 1 parenchymal brain lesion = 0.5 cm and = 4 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension. (Measurable intracranial lesions that have been previously irradiated and have not been shown to be progressing following irradiation should not be considered as target lesions).
* Patients may have received the following prior therapies:

1. Safety Lead-in, Phase 2 Randomized , Phase 2 Arm A Cohort 1: May have received prior local therapy for brain metastases including but not restricted to brain surgery, whole brain radiotherapy, stereotactic radiotherapy or stereotactic radiosurgery. Multiple local (brain) therapies or combinations of local therapies are allowed. For patients receiving local therapy to all brain lesions (including WBRT), progression of pre-existing lesions based on RECIST 1.1 (> 20% increase in longest diameter on baseline scan) or new measurable lesions are required. For patients receiving local therapy for some but not all lesions, disease progression based on RECIST 1.1 is not required as long as there are remaining brain lesions that are measurable and not previously treated.
2. Phase 2 Arm A Cohort 2: Received no prior local therapy (e.g., brain surgery, craniotomy, SRS or SRT) for brain metastases.
3. All patients (Safety Lead-In and Phase 2): May have received prior immunotherapy.
4. All patients (Safety Lead-In and Phase 2): If receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 2 weeks prior to first dose of study treatment (up to a total daily dose of 4mg of dexamethasone or equivalent).
* An Eastern Cooperation Oncology Group Performance Status (ECOG PS) of 0 or 1 and Karnofsky score = 80
* Adequate bone marrow, organ function and laboratory parameters

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with symptomatic brain metastasis.
* Uveal or mucosal melanoma.
* History of or current leptomeningeal metastases.
* Treatment with SRS or craniotomy within 14 days prior to start of study treatment, or treatment with whole-brain radiation within 28 days prior to study treatment. Patients who received local therapy should have complete recovery with no neurological sequelae.
* Either of the following:

1. Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start of study treatment;
2. Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown).
* Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6 months prior to enrollment. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
* Patient has not recovered to = Grade 1 from toxic effects of prior therapy before starting study treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2022
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Crows Nest Eye Surgery - Crows Nest
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Royal north shore center hospital dermatology clinics - st Leonards
Recruitment hospital [4] 0 0
Mater Imaging - Wollstonecraft
Recruitment postcode(s) [1] 0 0
2065 - Crows Nest
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2065 - st Leonards
Recruitment postcode(s) [4] 0 0
2065 - Wollstonecraft
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad Autónoma DE Buenosaires
Country [6] 0 0
Argentina
State/province [6] 0 0
Santa FE
Country [7] 0 0
Argentina
State/province [7] 0 0
Caba
Country [8] 0 0
Belgium
State/province [8] 0 0
Antwerpen
Country [9] 0 0
Italy
State/province [9] 0 0
Naples
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03911869