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Spots Global Cancer Trial Database for Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML

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Trial Identification

Brief Title: Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML

Official Title: A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)

Study ID: NCT01191801

Study Description

Brief Summary: This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

Detailed Description: The study includes additional objectives to ones listed above as Outcome Measures. These additional objectives also compared treatment groups in the following: CR + CRp rate, defined as CR + CRp based on modified IWG response criteria. Combined CR rate (CR+CRp+CRi). Percentage of patients who have post-treatment (subsequent) transplantation. Percentage of patients who received subsequent non-protocol therapy (including transplantation). Safety and tolerability. In keeping with FDA guidance for adaptive trial designs, the study incorporated an independent DSMB (Drug Safety Monitoring Board) to address potential uncertainty concerning the true treatment affect between the treatment groups and to address a deterioration of power from a small difference. Sunesis remained blinded and had no involvement in the interim data analysis, interpretation, or adaptive design. Based on the results of the interim data analysis the DSMB recommended an increase in the target number of deaths from 375 in 450 patients to 562 in 675 patients which based on a 5% dropout rate increased enrollment from 475 to 712. The primary analysis was performed when the target number of deaths had been achieved based on a permuted block randomization procedure, stratified by disease status (refractory, first relapse with duration of first CR or CRp ≥ 90 days and \< 12 months, or first relapse with duration of first CR or CRp ≥ 12 months and ≤ 24 months), age (\< 60 years or ≥ 60 years), and geographic location (US or outside US). The study included periods of screening, treatment / hematologic recovery, post-treatment follow-up, and long-term follow-up for survival. Follow-up was monthly during the first year, every 2 months during the second year, and every 3 months thereafter until death, withdrawal of consent, or loss to follow-up, whichever occurred first. Long-term follow-up began for all patients when the required number of deaths for primary analysis had been met; thereafter, survival data were collected every 4 months until death, withdrawal of consent, or loss to follow-up, whichever occurred first. The long term follow-up for this study continues at this time and the September 2014 date reflects database lock for primary analyses reflected in the Results Section. During long term follow-up Sunesis is not collecting Adverse Events.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Moores UCSD Cancer Center, La Jolla, California, United States

UCLA Division of Hematology/Oncology, Los Angeles, California, United States

Sharp Clinical Oncology Research, San Diego, California, United States

University of California San Francisco, San Francisco, California, United States

HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado, United States

George Washington University-Medical Faculty Associates, Washington, District of Columbia, United States

Holy Cross Hospital, Fort Lauderdale, Florida, United States

Baptist Cancer Institute, Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Georgia Health Sciences University, Augusta, Georgia, United States

Rush University Medical Center, Division of Hematology/Oncology, Chicago, Illinois, United States

University of Chicago, Chicago, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

St. Francis Medical Group Oncology and Hematology Specialists, Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Ochsner Clinic Foundation, New Orleans, Louisiana, United States

University of Michigan, Ann Arbor, Michigan, United States

Henry Ford Health System, Detroit, Michigan, United States

Ellis Fischel Cancer Center, University of Missouri Health Care, Columbia, Missouri, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

North Shore Long Island Jewish Health System, Lake Success, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Weill Cornell Medical College, New York, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

New York Medical College, Division of Oncology/Hematology, Valhalla, New York, United States

Mecklenburg Medical Group, Charlotte, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

University Hospitals fo Cleveland, Cleveland, Ohio, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Family Cancer Center, Memphis, Tennessee, United States

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States

UT Southwestern Medical Center at Dallas, Dallas, Texas, United States

The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia, Houston, Texas, United States

Cancer Care Centers of South Texas, San Antonio, Texas, United States

Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University, Morgantown, West Virginia, United States

The Canberra Hospital, Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Haematology Department, Gosford Hospital, Gosford, New South Wales, Australia

Westmead Hospital, Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia

Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia

Flinders Medical Centre, Bedford Park, South Australia, Australia

Andrew Love Cancer Center, Geelong Hospital, Barwon Health, Geelong, Victoria, Australia

The Alfred Hospital, Melbourne, Victoria, Australia

Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital, Parkville, Victoria, Australia

Royal Perth Hospital, Perth, Western Australia, Australia

Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie, Graz, , Austria

University Hospital for Internal Medicine V, Innsbruck Medical University, Innsbruck, , Austria

Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU, Salzburg, , Austria

AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1, Wien, , Austria

ZNA Middleheim Lindendreef 1, Antwerpen, , Belgium

ZNA Stuivenberg, Lange Beeldekensstraat 267, Antwerpen, , Belgium

AZ St.-Jan Brugge-Oostende AV, Brugge, , Belgium

Cliniques Universitaires Saint Luc, Brussels, , Belgium

UZ Leuven, campus Gasthuisberg, Department of Haematology, Leuven, , Belgium

H.-Hartziekenhuis Roeselare - Menen vzw, Roeselare, , Belgium

Division of Hematology, Vancouver General Hospital, Vancouver, British Columbia, Canada

Saint John Regional Hospital, Saint John, New Brunswick, Canada

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada

University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada

Charles LeMoyne Hospital, Greenfield Park, Quebec, Canada

Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie, Praha, Srobarova, Czechia

Fakultni nemocnice Brno, Interni hematoonkologicka klinika, Brno, , Czechia

Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie, Hradec Kralove, , Czechia

CHU Lille, Service des maladies du sang, Hopital Huriez, Lille, Lille Cedex, France

CHU Angers, Service des maladies du sang, Angers Cedex 01, , France

Hopital Avicenne- Departement Onco-hematologie, Bobigny, , France

Hopital Mignot, Le Chesnay, , France

Institut Paoli Calmettes, Marseille, , France

CHU Nantes Hotel Dieu, Service d'hematologie clinique, Nantes, , France

CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle, Pessac, , France

Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet, Pierre Benite, , France

Service d'hematologie- Hopital Purpan- CHU de Toulouse, Toulouse, , France

St. Johannes-Hospital, Duisburg, , Germany

Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt, Frankfurt, , Germany

Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation, Hamburg, , Germany

Medizinische Hochschule Hannover, Abteilung Hamatologie, Hannover, , Germany

SLK-Kliniken Heilbronn GmbH, Medizinische Klinik, Heilbronn, , Germany

Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik, Kiel, , Germany

Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie, Leipzig, , Germany

University Hospital of Muenster, Muenster, , Germany

Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik, Munich, , Germany

University of Debrecen Medical and Health Sciences Center, Debrecen, , Hungary

Petz Aladar County Hospital, Gyor, , Hungary

kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly, Kaposvar, , Hungary

Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika, Szeged, , Hungary

Ospedale "A. Perrino", U.O. Compessa di Ematologia, Brindisi, , Italy

Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate, Ferrara, , Italy

Ospedaliera Universitaria San Martino di Genova, Genova, , Italy

Ospedale "Vito Fazzi", U.O Ematologia, Lecce, , Italy

AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO, Napoli, , Italy

Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia, Novara, , Italy

Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia, Pavia, , Italy

Seoul National University Hospital, Seoul, , Korea, Republic of

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, , Korea, Republic of

Seoul St. Mary's Hospital, Seoul, , Korea, Republic of

Dept. of Hematology, Asan Medical Center, Seoul, , Korea, Republic of

Haematology Research, Auckland District Health Board, Auckland City Hospital, Grafton, Auckland, New Zealand

Canterbury Health Laboratories, Christchurch, , New Zealand

Department of Haematology, Waikato Hospital, Hamilton, , New Zealand

Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North, , New Zealand

Uniwersyteckle Centrum Kliniczne, Gdansk, , Poland

Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, , Poland

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital Universitario Vall d'Hebron, Barcelona, , Spain

Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Centro Oncologico MD Anderson International Espana, Madrid, , Spain

Hospital Universitario La Paz, Madrid, , Spain

Hospital Sont Llatzer, Palma de Mallorca, , Spain

Hospital Universitario de Salamanca, Salamanca, , Spain

Hospital Universitari Politecnic la Fe Hematology Department, Valencia, , Spain

Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, , United Kingdom

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, , United Kingdom

Department of Haematology, University Hospital of Wales, Cardiff, , United Kingdom

Queen's Centre for Oncology and Hematology, Castle Hill Hospital, Cottingham, , United Kingdom

Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust, Leicester, , United Kingdom

Department of Haematology, Royal Liverpool University Hospital, Liverpool, , United Kingdom

Department of Haematology, Guy's Hospital, London, , United Kingdom

Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary, Manchester, , United Kingdom

Contact Details

Name: Linda Neuman, MD

Affiliation: Sunesis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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