CompletedNCT02039726Updated Feb 24, 2021Results posted

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

A Phase 3 interventional study of Quizartinib and Salvage Chemotherapy in AML, sponsored by Daiichi Sankyo. Completed at 131 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 367
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

Conditions studied

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Keywords

Acute Myeloid Leukemia
AML
FMS-like tyrosine kinase 3
FLT3-ITD
Quizartinib
Leukemia
Tablets

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 367 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for United States [US] sites) prior to any study related procedures, including withdrawal of prohibited medications if applicable.
Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of Informed consent.
Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.
In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.
Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of ≥3% FLT3-ITD/total FLT3). If a specimen has been sent for FLT3-ITD testing at the central laboratory but the subject requires treatment for AML before the central FLT3-ITD test result is available, a local test result may be acceptable for randomization after consultation with the Medical Monitor.
Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.
Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non cytotoxic agents.
Serum creatinine ≤1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.
Serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
Total serum bilirubin ≤1.5×ULN.
Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5×ULN.

Exclusion criteria

Exclusion Criteria:

Acute Promyelocytic Leukemia (AML subtype M3).
AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior Myelodysplastic Syndrome (MDS).
History of another malignancy, unless the candidate has been disease-free for at least 5 years.
Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non hematologic toxicity related to HSCT.
History of or current, central nervous system involvement with AML.
Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
Prior treatment with quizartinib or participated in a prior quizartinib study.
Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).
Major surgery within 4 weeks prior to screening.
Radiation therapy within 4 weeks prior to screening.
Uncontrolled or significant cardiovascular disease
Active infection not well controlled by antibacterial or antiviral therapy.
Known infection with human immunodeficiency virus, or active hepatitis B or C, or other active clinically relevant liver disease.
Unwillingness to receive infusion of blood products according to the protocol.
In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period for at least 3 months after study completion. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and 105 days after the final study drug administration.
In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.
Pregnancy.
Female Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.
Medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
For subjects in the United Kingdom only: Refusal of permission to allow the subject's General Practitioner to be notified of their participation in the study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 367 participants (actual)

Study arms

Experimental
Quizartinib
Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.
Drug: Quizartinib
Active comparator
Salvage chemotherapy
Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
Drug: Salvage Chemotherapy

Interventions

DrugQuizartinib
20 or 30 mg quizartinib tablets administered orally once daily
Also known as: AC220
DrugSalvage Chemotherapy
Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles
Also known as: Standard of Care

What researchers measure

Primary outcomes

Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.
Time frame: At approximately 3 years 9 months

Secondary outcomes

Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.
Time frame: At approximately 3 years 9 months

Results

Posted Jan 27, 2020

Participant flow

A total of 367 participants who met the inclusion and none of the exclusion criteria were randomized (intent-to-treat population); 335 received study drug (safety analysis set).

Participant flow — Overall Study
Milestone	Quizartinib	Salvage Chemotherapy
Started	245	122
Ongoing (as of data cutoff)	45	16
Did not receive treatment	4	28
Completed	200	106
Not completed	45	16

Outcome measures

PrimaryOverall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.

Time frame:: At approximately 3 years 9 months
Reported as:: Median · weeks

Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
weeks	Quizartinib	Salvage Chemotherapy
Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy	27.0 (15.4 to 62.6)	20.4 (8.3 to 39.6)

Statistical analysis

Quizartinib vs Salvage Chemotherapy · P-value for HR=1 (1-sided) · p = 0.0185 · Hazard ratio (hr): 0.758 · 95% CI 0.584 to 0.983

SecondaryEvent-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.

Time frame:: At approximately 3 years 9 months
Reported as:: Median · weeks

Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
weeks	Quizartinib	Salvage Chemotherapy
Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy	6.0 (0.1 to 19.7)	3.7 (0.1 to 17.0)

Statistical analysis

Quizartinib vs Salvage Chemotherapy · P value for HR=1 (1-sided) · p = 0.2034 · Hazard ratio (hr): 0.898 · 95% CI 0.697 to 1.157

Adverse events

Collected over Treatment-emergent adverse events (TEAEs) were collected from the first dose of study drug to 30 days after the last dose (or longer if assessed as treatment related). All safety events are reported for participants in the Safety Analysis Set who received at least 1 dose of study drug or salvage chemotherapy.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Quizartinib	80/241 (33.2%)	168/241 (69.7%)	238/241 (98.8%)
Salvage Chemotherapy	16/94 (17%)	37/94 (39.4%)	91/94 (96.8%)

Most frequent serious events

Showing 10 of 164

Most frequent serious events
Event	Quizartinib	Salvage Chemotherapy
Febrile neutropeniaBlood and lymphatic system disorders	50/241	9/94
PneumoniaInfections and infestations	22/241	3/94
SepsisInfections and infestations	16/241	4/94
PyrexiaGeneral disorders	8/241	2/94
Escherichia sepsisInfections and infestations	2/241	3/94
Neutropenic sepsisInfections and infestations	7/241	2/94
AnemiaBlood and lymphatic system disorders	6/241	0/94
CellulitisInfections and infestations	6/241	0/94
Urinary tract infectionInfections and infestations	6/241	0/94
Hemorrhage intracranialNervous system disorders	5/241	2/94

Most frequent other events

Showing 10 of 78

Most frequent other events
Event	Quizartinib	Salvage Chemotherapy
NauseaGastrointestinal disorders	114/241	39/94
PyrexiaGeneral disorders	88/241	42/94
DysuriaRenal and urinary disorders	15/241	39/94
DiarrheaGastrointestinal disorders	68/241	34/94
AnemiaBlood and lymphatic system disorders	86/241	29/94
VomitingGastrointestinal disorders	80/241	20/94
HypokalemiaMetabolism and nutrition disorders	76/241	25/94
FatigueGeneral disorders	67/241	18/94
Electrocardiogram QT prolongedInvestigations	63/241	2/94
ThrombocytopeniaBlood and lymphatic system disorders	62/241	20/94

Baseline characteristics

Participants received standard of care salvage chemotherapy (administered subcutaneously \[LoDac\] or intravenously \[MEC and FLAG-IDA\]).

Age, Categorical
Age, Categorical(Participants)	Quizartinib	Salvage Chemotherapy	Total
<=18 years	0	0	0
Between 18 and 65 years	180	89	269
>=65 years	65	33	98

Age, Continuous
Age, Continuous(years)	Quizartinib	Salvage Chemotherapy	Total
Median	55.0 (19 to 81)	57.5 (18 to 78)	56.0 (18 to 81)

Sex: Female, Male
Sex: Female, Male(Participants)	Quizartinib	Salvage Chemotherapy	Total
Female	132	58	190
Male	113	64	177

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Quizartinib	Salvage Chemotherapy	Total
American Indian or Alaska Native	1	0	1
Asian	24	16	40
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	9	3	12
White	184	93	277
More than one race	0	0	0
Unknown or Not Reported	27	10	37

Region of Enrollment
Region of Enrollment(participants)	Quizartinib	Salvage Chemotherapy	Total
Singapore	0	2	2
Hong Kong	5	3	8
Hungary	1	0	1
United States	82	36	118
Czechia	2	0	2
United Kingdom	21	14	35
Spain	15	6	21
Canada	18	5	23
Netherlands	2	1	3
South Korea	11	7	18
Belgium	1	0	1
Taiwan	2	1	3
Poland	2	0	2
Italy	34	19	53
Australia	3	3	6
France	20	7	27
Serbia	1	0	1
Germany	25	18	43

Study locations

131 sites

City of Hope National Medical Center
Duarte, California 91010, United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California 90033, United States
UCLA Medical Center
Los Angeles, California 90095, United States
UC Davis Cancer Center
Sacramento, California 95817, United States
Stanford University Medical Center Stanford Comprehensive Cancer Center
Stanford, California 94305, United States
Yale University
New Haven, Connecticut 06520, United States
Emory Winship Cancer Institute
Atlanta, Georgia 30322, United States
University of Illinois at Chicago
Chicago, Illinois 60607, United States
University of Chicago
Chicago, Illinois 60637, United States
Franciscan Alliance
Indianapolis, Indiana 46237, United States
University of Kansas Medical Center Research Institute Inc
Westwood, Kansas 66205, United States
LSU Health Sciences Center Feist Weiller Cancer Center
Shreveport, Louisiana 71103, United States
University of Maryland
Baltimore, Maryland 21201, United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215, United States
University of Michigan Health System
Ann Arbor, Michigan 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Washington University School of Medicine
Saint Louis, Missouri 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska 68198, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601, United States
Roswell Park Cancer Institute
Buffalo, New York 14263, United States
Columbia University Medical Center
New York, New York 10032, United States
University of Rochester
Rochester, New York 14642, United States
NY Medical College
Valhalla, New York 10595, United States
UNC Linebreger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599, United States
Duke Cancer Institute at Duke University Health System
Durham, North Carolina 27710, United States
Wake Forest University Baptist Health
Winston-Salem, North Carolina 27157, United States
University of Cincinnati
Cincinnati, Ohio 45267, United States
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon 97239, United States
Geisinger Medical Center
Danville, Pennsylvania 17822, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104, United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232, United States
MD Anderson Center, The University of Texas
Houston, Texas 77030, United States
Swedish Cancer Institute
Seattle, Washington 98104, United States
The Canbera Hospital
Garran, New South Wales 2605, Australia
Westmead Hospital
Westmead, New South Wales 2145, Australia
The Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000, Australia
The Queen Elizabeth Hospital
Woodville, South Australia 5011, Australia
Alfred Hospital
Melbourne, Victoria 3004, Australia
ZNA Stuivenberg
Antwerpen, BE 2060, Belgium
UCL St Luc
Brussels, BE 1200, Belgium
Leuven UZ Gasthuisberg
Leuven, BE 3000, Belgium
University of Alberta Hospital
Edmonton, Alberta T6G 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9, Canada
Princess Margaret Cancer Centre Princess Margaret Hospital
Toronto, Ontario M5G2M9, Canada
Klinička Bolinca Merkur
Zagreb, 10000, Croatia
Kliničko Bolnički Centar Zagreb
Zagreb, 10000, Croatia
Fakultni nemocnice Brno
Brno, 62500, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77900, Czechia
CHU de Caen
Caen, 14000, France
Centre Hospitalier Universitaire Grenoble Hopital Michalon
Grenoble, 38043, France
Centre Hospitalier de Versailles
Le Chesnay, 78157, France
Hopital de la Conception
Marseille, 13385, France
Centre Hospitalier Universitaire Nantes
Nantes, 44035, France
Hôpital Saint Louis
Paris, 75010, France
Hopital Saint-Antoine
Paris, 75571, France
Hopital Haut Leveque Centre Francois Magendie
Pessac, 33604, France
Centre Henri-Becquerel
Rouen, 76038, France
Centre Hospitalier Universitaire Purpan
Toulouse, 31059, France
Charité Universitätsmedizin Berlin
Berlin, 12200, Germany
Charité Campus Virchow Klinikum
Berlin, 13353, Germany
Klinikum Braunschweig
Braunschweig, 38114, Germany
Universitatsklinikum Dresden
Dresden, 01307, Germany
Klinikum der Johann Wolfgang-Goethe-Universität
Frankfurt, 60590, Germany
Universitätsklinikum Halle
Halle, 06120, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Uniklinik Heidelberg Medizinische Klinik und Poliklinik V
Heidelberg, 69120, Germany
Universitätsklinikum Jena
Jena, 07743, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
University Mainz
Mainz, 55131, Germany
Universitätsklinikum Giessen und Marburg GmbH
Marburg, 35043, Germany
LMU München Klinikum Großhadern
Munchen, 81377, Germany
Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie
Münster, 48149, Germany
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrad 6725, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet
Debrecen, Hajdu Bihar 4032, Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika
Budapest, Pest 1083, Hungary
AOU Policlinico Consorziale di Bari
Bari, 70124, Italy
Università di Bologna
Bologna, 40138, Italy
Unità Operativa di Ematologia e Unità Operativa CTMO
Cagliari, Italy
Arcispedale S Anna
Ferrara, 44124, Italy
AOU Careggi
Firenze, 50134, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
Opsedale San Martino di Genova
Genova, 16132, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
L'UOC di Ematologia del Policlinico Tor Vergata
Rome, 00133, Italy
Policlinico Universitario Agostino Gemelli
Rome, 00168, Italy
Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte
Siena, 53100, Italy
Ospedale di Circolo-a Fondazione Macchi
Varese, 21100, Italy
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of
Kyungpook National University Hospital
Daegu, 700-721, Korea, Republic of
Seoul National University Hospital
Seoul, 110-744, Korea, Republic of
Samsung Medical Center
Seoul, 135-710, Korea, Republic of

Showing the first 100 of 131 sites across 19 countries.

References and documents

Publications

Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Kramer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Yin O. Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021 Apr;87(4):513-523. doi: 10.1007/s00280-020-04204-y. Epub 2021 Jan 8. PubMed 33415416 ↗
Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Kramer A, Dombret H, Hogge D, Jonas BA, Leung AY, Mehta P, Montesinos P, Radsak M, Sica S, Arunachalam M, Holmes M, Kobayashi K, Namuyinga R, Ge N, Yver A, Zhang Y, Levis MJ. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):984-997. doi: 10.1016/S1470-2045(19)30150-0. Epub 2019 Jun 4. Erratum In: Lancet Oncol. 2019 Jul;20(7):e346. doi: 10.1016/S1470-2045(19)30426-7. PubMed 31175001 ↗
Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31. PubMed 29859851 ↗

Study documents

Protocol and statistical analysis plan · Jun 30, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02039726
Lead sponsor: Daiichi Sankyo
Responsible party: Sponsor
First posted: Jan 20, 2014
Start date: May 2014
Primary completion: Feb 22, 2018
Completion: Sep 8, 2020
Results posted: Jan 27, 2020
Last update: Feb 24, 2021

Study contacts

Jorge E. Cortes, MD

principal investigator · M.D. Anderson Cancer Center

Global Clinical Leader

study director · Daiichi Sankyo

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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