Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03416179




Registration number
NCT03416179
Ethics application status
Date submitted
21/12/2017
Date registered
31/01/2018

Titles & IDs
Public title
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Scientific title
A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA
Secondary ID [1] 0 0
2017-002822-19
Secondary ID [2] 0 0
B1371019
Universal Trial Number (UTN)
Trial acronym
BRIGHT AML1019
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - glasdegib
Treatment: Drugs - daunorubicin + cytarabine
Treatment: Drugs - azacitidine
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - glasdegib
Treatment: Drugs - cytarabine
Treatment: Surgery - HSCT

Experimental: Arm A (Intensive Study) - Glasdegib + '7+3' Induction(s)

Placebo comparator: Arm B (Intensive Study) - Placebo + '7+3' Induction(s)

Experimental: Arm A (Non-intensive study) - Glasdegib + azacitidine

Placebo comparator: Arm B (Non-intensive study) - Placebo + azacitidine


Treatment: Drugs: glasdegib
Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.

Following consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.

Daily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.

Treatment: Drugs: daunorubicin + cytarabine
'7+3' (cytarabine 100 mg/m2, IV for 7 days by continuous infusion and daunorubicin 60 mg/m2 for 3 days).

If a second induction is needed, Investigators may choose either a 5 day cytarabine continuous infusion plus daunorubicin for 2 days ('5+2') or a 7 day cytarabine continuous infusion plus daunorubicin for 3 days ('7+3');

Treatment: Drugs: azacitidine
Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.

Treatment: Drugs: Placebo
Matching placebo (PO) given on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, placebo will be administered daily for up to 2 years after randomization or until they have MRD negative disease, whichever comes first.

Daily placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.

Treatment: Drugs: Placebo
Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.

Treatment: Drugs: glasdegib
Glasdegib 100 mg PO QD is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment.

Subjects will continue glasdegib until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.

Treatment: Drugs: cytarabine
Consolidation with single agent cytarabine 3 g/m2 IV for adults \<60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.

Treatment: Surgery: HSCT
If required, and done per standard of care post Induction(s).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intensive Study: Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to 25 months
Primary outcome [2] 0 0
Non-intensive Study: Overall Survival (OS)
Timepoint [2] 0 0
Baseline up to 25 months
Secondary outcome [1] 0 0
Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire
Timepoint [1] 0 0
Post-baseline up to Week 8
Secondary outcome [2] 0 0
Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12
Timepoint [2] 0 0
Post-baseline up to Week 12
Secondary outcome [3] 0 0
Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
Timepoint [3] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [4] 0 0
Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
Timepoint [4] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [5] 0 0
Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg)
Timepoint [5] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [6] 0 0
Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg)
Timepoint [6] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [7] 0 0
Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)
Timepoint [7] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [8] 0 0
Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)
Timepoint [8] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [9] 0 0
Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)
Timepoint [9] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [10] 0 0
Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)
Timepoint [10] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [11] 0 0
Intensive Study: Percentage of Participants With Partial Remission (PR)
Timepoint [11] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [12] 0 0
Non-intensive Study: Percentage of Participants With Partial Remission (PR)
Timepoint [12] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [13] 0 0
Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)
Timepoint [13] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [14] 0 0
Intensive Study: Duration of Response (DoRi)
Timepoint [14] 0 0
From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years)
Secondary outcome [15] 0 0
Non-intensive Study: Duration of Response (DoRi) or (DoRh)
Timepoint [15] 0 0
From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years)
Secondary outcome [16] 0 0
Non-intensive Study: Time to Response
Timepoint [16] 0 0
From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years)
Secondary outcome [17] 0 0
Intensive Study: Event-free Survival (EFS)
Timepoint [17] 0 0
From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years)
Secondary outcome [18] 0 0
Non-intensive Study: Event-free Survival (EFS)
Timepoint [18] 0 0
From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years)
Secondary outcome [19] 0 0
Intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score
Timepoint [19] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [20] 0 0
Non-intensive Study: MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Score
Timepoint [20] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [21] 0 0
Intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score
Timepoint [21] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [22] 0 0
Non-intensive Study: EuroQoL 5 Dimension Questionnaire 5-Level Version (EQ-5D-5L) Score
Timepoint [22] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [23] 0 0
Intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)
Timepoint [23] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [24] 0 0
Non-intensive Study: EuroQoL Visual Analogue Scale (EQ-VAS)
Timepoint [24] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [25] 0 0
Intensive Study: Participants Global Impression of Symptoms (PGIS)
Timepoint [25] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [26] 0 0
Non-intensive Study: Participants Global Impression of Symptoms (PGIS)
Timepoint [26] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [27] 0 0
Intensive Study: Participants Global Impression of Change (PGIC)
Timepoint [27] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [28] 0 0
Non-intensive Study: Participants Global Impression of Change (PGIC)
Timepoint [28] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [29] 0 0
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03
Timepoint [29] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [30] 0 0
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03
Timepoint [30] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [31] 0 0
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03
Timepoint [31] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [32] 0 0
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03
Timepoint [32] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [33] 0 0
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Timepoint [33] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [34] 0 0
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Timepoint [34] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [35] 0 0
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Timepoint [35] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [36] 0 0
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Timepoint [36] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [37] 0 0
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Timepoint [37] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [38] 0 0
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03
Timepoint [38] 0 0
Day 1 up to maximum of 3 years
Secondary outcome [39] 0 0
Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib
Timepoint [39] 0 0
Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr
Secondary outcome [40] 0 0
Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib
Timepoint [40] 0 0
Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1
Secondary outcome [41] 0 0
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval
Timepoint [41] 0 0
Day 1 up to maximum of 2 years
Secondary outcome [42] 0 0
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval
Timepoint [42] 0 0
Day 1 up to maximum of 3 years

Eligibility
Key inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):

1. Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with:

* AML arising from MDS or another antecedent hematologic disease (AHD).
* AML after previous cytotoxic therapy or radiation (secondary AML).
2. 18 years of age (In Japan, 20 years of age).
3. Adequate Organ Function as defined by the following:

* Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.
* Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).
* Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.
4. QTc interval 470 msec using the Fridericia correction (QTcF).
5. All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines.

* For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.
6. Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.
7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.
8. Female subjects of non childbearing potential must meet at least 1 of the following criteria:

1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
2. Have medically confirmed ovarian failure; or
3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
9. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with any of the following characteristics/conditions will not be included in the study:

1. Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).
2. AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.

* Complex genetics may include t(9;22) cytogenetic translocation.
3. Subjects with known active CNS leukemia.
4. Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.
5. Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
6. Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.
7. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.
8. Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
9. Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.
10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.
12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
13. Concurrent administration of herbal preparations.
14. Major surgery or radiation within 4 weeks of starting study treatment.
15. Documented or suspected hypersensitivity to any one of the following:

* For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.
* For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.
16. Known active drug or alcohol abuse.
17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
18. Pregnant females or breastfeeding female subjects.
19. Known recent or active suicidal ideation or behavior.
20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2022
Sample size
Target
Accrual to date
Final
730
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
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
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Austria
State/province [11] 0 0
Salzburg
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Brugge
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
Manitoba
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatchewan
Country [20] 0 0
China
State/province [20] 0 0
Anhui
Country [21] 0 0
China
State/province [21] 0 0
Fujian
Country [22] 0 0
China
State/province [22] 0 0
Guangdong
Country [23] 0 0
China
State/province [23] 0 0
Hebei
Country [24] 0 0
China
State/province [24] 0 0
Henan
Country [25] 0 0
China
State/province [25] 0 0
Hubei
Country [26] 0 0
China
State/province [26] 0 0
Sichuan
Country [27] 0 0
China
State/province [27] 0 0
Tianjin
Country [28] 0 0
China
State/province [28] 0 0
Zhejiang
Country [29] 0 0
China
State/province [29] 0 0
Shanghai
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava - Poruba
Country [32] 0 0
Czechia
State/province [32] 0 0
Ostrava-Poruba
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 10
Country [34] 0 0
France
State/province [34] 0 0
Créteil
Country [35] 0 0
France
State/province [35] 0 0
Nantes cedex 1
Country [36] 0 0
France
State/province [36] 0 0
Nantes cedex
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
Pierre-Benite cedex
Country [39] 0 0
France
State/province [39] 0 0
Villejuif cedex
Country [40] 0 0
Germany
State/province [40] 0 0
Bavaria
Country [41] 0 0
Germany
State/province [41] 0 0
Hesse
Country [42] 0 0
Germany
State/province [42] 0 0
North Rhine Westphalia
Country [43] 0 0
Germany
State/province [43] 0 0
North Rhine-westphalia
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
Hannover
Country [46] 0 0
Hungary
State/province [46] 0 0
Debrecen
Country [47] 0 0
Hungary
State/province [47] 0 0
Gyor
Country [48] 0 0
Hungary
State/province [48] 0 0
Kaposvar
Country [49] 0 0
Hungary
State/province [49] 0 0
Nyiregyhaza
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Petah Tikva
Country [53] 0 0
Italy
State/province [53] 0 0
Ancona
Country [54] 0 0
Italy
State/province [54] 0 0
AN
Country [55] 0 0
Italy
State/province [55] 0 0
FE
Country [56] 0 0
Italy
State/province [56] 0 0
PU
Country [57] 0 0
Italy
State/province [57] 0 0
SI
Country [58] 0 0
Italy
State/province [58] 0 0
Bologna
Country [59] 0 0
Italy
State/province [59] 0 0
Siena
Country [60] 0 0
Japan
State/province [60] 0 0
Aichi
Country [61] 0 0
Japan
State/province [61] 0 0
Fukui
Country [62] 0 0
Japan
State/province [62] 0 0
Gunma
Country [63] 0 0
Japan
State/province [63] 0 0
Hyogo
Country [64] 0 0
Japan
State/province [64] 0 0
Kanagawa
Country [65] 0 0
Japan
State/province [65] 0 0
Miyagi
Country [66] 0 0
Japan
State/province [66] 0 0
Osaka
Country [67] 0 0
Japan
State/province [67] 0 0
Shizuoka
Country [68] 0 0
Japan
State/province [68] 0 0
Tokyo
Country [69] 0 0
Japan
State/province [69] 0 0
Akita
Country [70] 0 0
Japan
State/province [70] 0 0
Fukuoka
Country [71] 0 0
Japan
State/province [71] 0 0
Kumamoto
Country [72] 0 0
Japan
State/province [72] 0 0
Nagasaki
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Jeollabuk-do
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Busan
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Daegu
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Incheon
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Mexico
State/province [78] 0 0
MÉX
Country [79] 0 0
Mexico
State/province [79] 0 0
Nuevo LEON
Country [80] 0 0
Poland
State/province [80] 0 0
Gdansk
Country [81] 0 0
Poland
State/province [81] 0 0
Lodz
Country [82] 0 0
Romania
State/province [82] 0 0
Cluj
Country [83] 0 0
Romania
State/province [83] 0 0
Dolj
Country [84] 0 0
Romania
State/province [84] 0 0
Bucharest
Country [85] 0 0
Romania
State/province [85] 0 0
Bucuresti
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Moscow
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Nizhniy Novgorod
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Ryazan
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Saint Petersburg
Country [90] 0 0
Spain
State/province [90] 0 0
Barcelona
Country [91] 0 0
Spain
State/province [91] 0 0
Lleida
Country [92] 0 0
Spain
State/province [92] 0 0
Madrid
Country [93] 0 0
Spain
State/province [93] 0 0
Sevilla
Country [94] 0 0
Spain
State/province [94] 0 0
Valencia
Country [95] 0 0
Sweden
State/province [95] 0 0
Orebro
Country [96] 0 0
Sweden
State/province [96] 0 0
Stockholm
Country [97] 0 0
Taiwan
State/province [97] 0 0
Tainan
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taipei
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taoyuan City
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Surrey
Country [101] 0 0
United Kingdom
State/province [101] 0 0
WEST Midlands
Country [102] 0 0
United Kingdom
State/province [102] 0 0
London

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/NCT03416179