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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02348489
Other study ID # SGI-110-04
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 19, 2015
Est. completion date June 17, 2019

Study information

Verified date December 2020
Source Astex Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 815
Est. completion date June 17, 2019
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification. Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed. Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER: 1. =75 years of age OR 2. <75 years of age with at least 1 of the following: i. Poor performance status (ECOG) score of 2-3. ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of: 1. Left ventricular ejection fraction (LVEF) =50%. 2. Lung diffusing capacity for carbon monoxide (DLCO) =65% of expected. 3. Forced expiratory volume in 1 second (FEV1) =65% of expected. 4. Chronic stable angina or congestive heart failure controlled with medication. iii. Liver transaminases >3 × upper limit of normal (ULN). iv. Other contraindication(s) to anthracycline therapy (must be documented). v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization. Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas =30 mL/min. Exclusion Criteria: Candidate for intensive remission induction chemotherapy at the time of enrollment. Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators. Known extramedullary central nervous system (CNS) AML. Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy. Prior treatment with decitabine or azacitidine. Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients. Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed. Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol. Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute (LPM) oxygen.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SGI-110 (guadecitabine)
Investigational medicinal product
Treatment Choice
Choice of one: cytarabine, decitabine, or azacitidine

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Monash Medical Centre Clayton Victoria
Australia Concord Repatriation General Hospital Concord New South Wales
Australia Austin Health Heidelberg Victoria
Austria Medizinische Universität Graz Graz Styria
Austria Hanusch Krankenhaus Wiener Gebietskrankenkasse Wien Vienna
Belgium Algemeen Ziekenhuis Sint-Jan Brugge West-vlaanderen
Belgium Grand Hôpital de Charleroi Charleroi Hainaut
Belgium UZ Gent Ghent Oost-vlaanderen
Bulgaria UMHAT 'Sveti Georgi' EAD Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD Varna
Canada Tom Baker Cancer Center Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada The Ottawa Hospital Ottawa Ontario
Canada Princess Margaret Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Czechia Fakultní nemocnice Brno Brno Jihormoravsky KRAJ
Czechia Fakultní nemocnice Královské Vinohrady Praha 10
Czechia Všeobecná fakultní nemocnice v Praze Praha 2 Praha
Denmark Aarhus University Hospital Aarhus
Denmark Rigshospitalet-Copenhagen University Hospital Copenhagen
Denmark Odense University Hospital Odense
Finland Helsinki University Central Hospital Helsinki
Finland Tampere University Hospital Tampere Southern Finland
France Hôpital Hôtel-Dieu Bayonne Aquitaine
France Centre Hospitalier Universitaire Grenoble La Tronche Rhone-alpes
France CHRU de Limoges - Hôpital Dupuytren Limoges Cedex Limousin, Lorraine
France Centre Léon Bérard Lyon Cedex 08 Rhone-alpes
France Institut Paoli Calmettes Marseille Cedex 9 Provence Alpes COTE D'azur
France GHR Mulhouse Sud-Alsace Mulhouse Cedex Alsace
France Hôpital Hôtel-Dieu Nantes cedex 1 PAYS DE LA Loire
France Centre Antoine Lacassagne Nice Provence Alpes COTE D'azur
France Hôpital Saint Louis Paris Cedex 10 Ile-de-france
France Centre Hospitalier Lyon Sud Pierre Bénite Cedex Rhone-alpes
France Centre Henri-Becquerel Rouen Cedex 1 Haute-normandie
France Centre Hospitalier Universitaire de Toulouse Toulouse cedex 9 Midi-pyrenees
Germany Städtisches Klinikum Braunschweig gGmbH Braunschweig Niedersachsen
Germany Marien Hospital Düsseldorf GmbH Düsseldorf Nordrhein-westfalen
Germany Universitätsklinikum Frankfurt Goethe Universität Frankfurt am Main Hessen
Germany Universitaetsklinikum Freiburg Freiburg Baden-wuerttemberg
Germany Universitätsklinikum Schleswig-Holstein Kiel Schleswig-holstein
Germany Universitätsklinikum Ulm Ulm Baden-wuerttemberg
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen Baden-wuerttemberg
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár
Hungary Bacs-Kiskun Megyei Korhaz Kecskemét Bacs-kiskun
Italy Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria Alessandria
Italy Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Bologna
Italy Azienda Ospedaliera Ospedale di Busto Arsizio Busto Arsizio
Italy Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino Catania
Italy IRCCS Azienda Ospedaliera Universitaria San Martino - IST Genova
Italy Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
Italy Azienda Ospedaliero-Universitaria Policlinico di Modena Modena
Italy AORN A. Cardarelli Napoli
Italy Azienda Ospedaliero-Univesitaria San Luigi Gonzaga Orbassano Torino
Italy Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Pesaro E Urbino
Italy IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture Rionero in Vulture Potenza
Italy Azienda Policlinico Umberto I di Roma Roma
Italy Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine Udine
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Jeollanam-do
Korea, Republic of Seoul National University Hospital Jongno Gu Seoul
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul Saint Mary's Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Ulsan University Hospital Ulsan
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich Chorzów Slaskie
Poland Wojewodzki Szpital Specjalistyczny im. M. Kopernika Lódz Lodzkie
Poland Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Lublin Lubelskie
Poland Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Opolskie
Poland Instytut Hematologii i Transfuzjologii Warszawa Mazowieckie
Poland Samodzielny Publiczny Centralny Szpital Kliniczny Warszawa Mazowieckie
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Wroclaw Dolnoslaskie
Romania Institutul Regional de Oncologie Iasi Iasi
Romania Spitalul Clinic Judetean de Urgenta Tirgu-Mures Targu-Mures Mures
Russian Federation Sverdlovsk Regional Clinical Hospital #1 Ekaterinburg
Russian Federation Ryazan Regional Clinical Hospital Ryazan
Russian Federation Saratov State Medical University Saratov
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Centre of Vojvodina Novi Sad
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital Vall d´Hebrón Barcelona
Spain Hospital San Pedro de Alcantara Caceres
Spain Hospital General Virgen de las Nieves Granada
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Clínico Universitario de Salamanca Salamanca
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Sweden Skånes Universitetssjukhus i Lund Lund Skane
Sweden Karolinska University Hospital Huddinge Stockholm
Taiwan China Medical University Hospital Taichung
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Medical Foundation-LinKou Branch Tao-Yuan Taoyuan
United Kingdom Medway Maritime Hospital Gillingham Kent
United Kingdom Chelsea and Westminster Hospital NHS Foundation Trust London England
United Kingdom King's College Hospital London England
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Roswell Park Cancer Institute Buffalo New York
United States University of Chicago Chicago Illinois
United States University Hospitals Monarch Medical Center Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Duke Cancer Center Durham North Carolina
United States John Theurer Cancer Center at Hackensack Hackensack New Jersey
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States MD Anderson Cancer Center Houston Texas
United States Scripps Cancer Center La Jolla California
United States University of Southern California Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia University Medical Center New York New York
United States Weill Cornell Medical College New York New York
United States Temple University Philadelphia Pennsylvania
United States Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Mayo Clinic Cancer Center Scottsdale Arizona
United States Stony Brook University Medical Center Stony Brook New York
United States University of Kansas Medical Center Westwood Kansas

Sponsors (1)

Lead Sponsor Collaborator
Astex Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With a Complete Response (CR) Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist. Up to 38 months (median follow-up of 25.5 months)
Primary Overall Survival Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause. At 676 death events (up to 38 months)
Secondary Number of Participants With Composite CR (CRc) CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi). Up to 38 months (median follow-up of 25.5 months)
Secondary Number of Days Alive and Out of the Hospital The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day. Month 6
Secondary Progression-free Survival (PFS) Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause. Up to 38 months (median follow-up of 25.5 months)
Secondary Number of Red Blood Cell or Platelet Transfusions The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit. Month 6
Secondary Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state. Baseline to Month 6
Secondary Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized. Baseline to Month 6
Secondary Duration of CR Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or = 5% leukemic blasts in BM. Up to 38 months (median follow-up of 25.5 months)
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