A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
BRIGHT AML1019
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
4 other identifiers
interventional
730
21 countries
146
Brief Summary
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2018
Typical duration for phase_3
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2020
CompletedResults Posted
Study results publicly available
June 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedApril 21, 2023
April 1, 2023
2.1 years
December 21, 2017
June 2, 2021
April 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intensive Study: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
Baseline up to 25 months
Non-intensive Study: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.
Baseline up to 25 months
Secondary Outcomes (42)
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
Post-baseline up to Week 8
Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12
Post-baseline up to Week 12
Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
Day 1 up to maximum of 2 years
Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)
Day 1 up to maximum of 3 years
Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg)
Day 1 up to maximum of 2 years
- +37 more secondary outcomes
Study Arms (4)
Arm A (Intensive Study)
EXPERIMENTALGlasdegib + '7+3' Induction(s)
Arm B (Intensive Study)
PLACEBO COMPARATORPlacebo + '7+3' Induction(s)
Arm A (Non-intensive study)
EXPERIMENTALGlasdegib + azacitidine
Arm B (Non-intensive study)
PLACEBO COMPARATORPlacebo + azacitidine
Interventions
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.
'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');
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.
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.
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.
If required, and done per standard of care post Induction(s).
Eligibility Criteria
You may qualify if:
- 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).
- years of age (In Japan, 20 years of age).
- 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.
- QTc interval 470 msec using the Fridericia correction (QTcF).
- 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.
- 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.
- 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.
- Female subjects of non childbearing potential must meet at least 1 of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- +6 more criteria
You may not qualify if:
- Subjects with any of the following characteristics/conditions will not be included in the study:
- Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).
- AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.
- Complex genetics may include t(9;22) cytogenetic translocation.
- Subjects with known active CNS leukemia.
- Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.
- Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
- 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.
- 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.
- Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
- Subjects with left ventricular ejection fraction (LVEF) \<50% are excluded from the Intensive Chemotherapy Study only.
- Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
- 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.
- Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
- Concurrent administration of herbal preparations.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (149)
UCLA Department of Medicine
Los Angeles, California, 90095, United States
UCLA Drug Information/Investigational Drugs
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology Clinic
Los Angeles, California, 90095, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
University of California, San Francisco
San Francisco, California, 94143, United States
UCLA Hematology/Oncology - Westlake Village
Westlake Village, California, 91361, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Tufts Medical Center Investigational Drug Pharmacy
Boston, Massachusetts, 02111, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City, Missouri, 64132, United States
Northwell Health/Monter Cancer Center
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Blood Cancer and Stem Cell Transplant Clinic
San Antonio, Texas, 78229, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
Salzburg, 5020, Austria
Uniklinikum Salzburg, Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
Vienna, 1130, Austria
AZ Sint-Jan Brugge-Oostende av
Bruges, B-8000, Belgium
Universitaire Ziekenhuizen Brussel (UZ Brussel)
Brussels, B-1090, Belgium
Universitaire Ziekenhuizen Brussel
Brussels, B-1090, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, B-3000, Belgium
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Anhui Provincial Hospital
Hefei, Anhui, 230071, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317, China
Hebei Yanda Lu Daopei Hospital
Langfang, Hebei, 065201, China
Henan Provincial People's Hospital/Hematology Department
Zhengzhou, Henan, 450003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, 430030, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
The First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno
Brno, 625 00, Czechia
Nemocnicni lekarna
Brno, 625 00, Czechia
Ustavni lekarna
Ostrava - Poruba, 708 52, Czechia
Klinika hematoonkologie
Ostrava-Poruba, 708 52, Czechia
Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Ústavni lékárna
Prague, 100 34, Czechia
CHU Henri Mondor
Créteil, 94010, France
CHU de Nantes Hotel Dieu
Nantes, 44093, France
CHU de Nantes
Nantes, 44093, France
Hopital Saint Louis
Paris, 75010, France
Centre Hospitalier Lyon Sud - Service d'Hematologie
Pierre-Bénite, 69495, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum der Universitaet Muenchen
Munich, Bavaria, 81377, Germany
Philipps-Universitaet Marburg
Marburg, Hesse, 35032, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
Debrecen, 4032, Hungary
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
Debrecen, 4032, Hungary
Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály
Győr, 9024, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia
Nyíregyháza, 4400, Hungary
Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz,
Nyíregyháza, 4400, Hungary
Rambam Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center (Ein Kerem)
Jerusalem, 91120, Israel
Hemato-oncology ambulatory Service
Petah Tikva, 4941492, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492, Israel
AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
Torrette Di Ancona, Ancona, 60126, Italy
SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
Torette Di Ancona, AN, 60126, Italy
A.O.U. di Ferrara- Arcispedale Sant'Anna,
Cona, Ferrara, FE, 44124, Italy
AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -
Pesaro, PU, 61122, Italy
Azienda Ospedaliera Universitaria Senese.
Siena, SI, 53100, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, 589-8511, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, 190-0014, Japan
Akita University Hospital
Akita, 010-8543, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Instituto Nacional de Cancerología
México, MÉX, 14080, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
WWCOiT im. M. Kopernika w Lodzi
Lodz, 93-513, Poland
Institutul Oncologic 'Prof. Dr. Ion Chiricuta'
Cluj-Napoca, Cluj, 400124, Romania
Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie
Craiova, Dolj, 200136, Romania
Sp. Clinic de Urgenta Militar Central Dr. Carol Davila
Bucharest, 010825, Romania
Spitalul Clinic Coltea, Clinica de Hematologie
Bucharest, 030171, Romania
State Budgetary Healthcare Institution of Moscow
Moscow, 129301, Russia
SBHI NNR NN RCH n. a. N.A. Semashko
Nizhny Novgorod, 603126, Russia
State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)
Ryazan, 390039, Russia
V.A Almazov NMRC
Saint Petersburg, 197341, Russia
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Clinical Trial Center, Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hospital del Mar
Barcelona, 08003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Arnau de Vilanova
Lleida, 25198, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Universitetssjukhuset Orebro
Örebro, 701 85, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86, Sweden
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan, 333, Taiwan
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, WEST Midlands, B15 2TH, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Related Publications (2)
Sekeres MA, Montesinos P, Novak J, Wang J, Jeyakumar D, Tomlinson B, Mayer J, Jou E, Robak T, Taussig DC, Dombret H, Merchant A, Shaik N, O'Brien T, Roh W, Liu X, Ma W, DiRienzo CG, Chan G, Cortes JE. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. Leukemia. 2023 Oct;37(10):2017-2026. doi: 10.1038/s41375-023-02001-z. Epub 2023 Aug 21.
PMID: 37604981DERIVEDCortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13.
PMID: 31516032DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In this study, inadvertently a participant was counted twice for an non-SAE "Pyrexia" at PCD, at SCD update this duplicity has been rectified. Due to this reason total number of participants affected by non-SAE in non-intensive placebo arm was updated to "148".
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2017
First Posted
January 31, 2018
Study Start
April 20, 2018
Primary Completion
June 5, 2020
Study Completion
January 17, 2022
Last Updated
April 21, 2023
Results First Posted
June 25, 2021
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
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.