AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy
1 other identifier
interventional
637
16 countries
135
Brief Summary
This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2007
Typical duration for phase_3
135 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
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 18, 2007
CompletedFirst Posted
Study publicly available on registry
October 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 6, 2019
October 1, 2019
3.7 years
October 18, 2007
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy.
Until death from any cause
Secondary Outcomes (6)
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate
Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.
Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response
Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression
Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety
Until death
- +1 more secondary outcomes
Study Arms (2)
Amrubicin
EXPERIMENTALAmrubicin
Topotecan
ACTIVE COMPARATORTopotecan
Interventions
Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course
Eligibility Criteria
You may qualify if:
- Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
- SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression \>/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression \< 90 days after completing first-line chemotherapy);
- Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
- Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
- No more than 1 prior chemotherapy regimen;
- At least 18 years of age;
- ECOG performance status of 0 - 1
You may not qualify if:
- Chest radiotherapy with curative intent to the primary disease complex \</= 28 days prior to first dose; CNS radiotherapy \</= 21 days prior to first dose; radiotherapy to all other areas \</= 7 days prior to first dose;
- Prior anthracycline, topotecan, or irinotecan treatment.
- Prior anthracycline or topotecan treatment.
- Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (140)
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
Arizona Oncology Associates
Tucson, Arizona, 85704, United States
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, 72205, United States
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, 93720, United States
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048, United States
University of Colorado Health Science Centre
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Center - Midtown (Main)
Denver, Colorado, 80218, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
Florida Oncology Associates
Orange Park, Florida, 32073, United States
Sacred Heart Medical Oncology
Pensacola, Florida, 32504, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30809, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
Cancer & Hematology Specialists of Chicago (Main)
Niles, Illinois, 60714, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Cancer Care at Blessing Hospital
Quincy, Illinois, 62301, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Hope Center
Terre Haute, Indiana, 47802, United States
Kansas City Cancer Center (Main)
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC
Metairie, Louisiana, 70006, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074, United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Alliance Hematology Oncology, P.A. (Main)
Westminster, Maryland, 21157, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, 49048, United States
Michigan Hematology & Oncology Institute
Southgate, Michigan, 48195, United States
University of Minnesota Medical Center, Cancer Center
Minneapolis, Minnesota, 55455, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64507, United States
Comprehensive Care Centers of Nevada (Main)
Las Vegas, Nevada, 89169, United States
New York Oncology Hematology, P.C.
Latham, New York, 12110-0610, United States
SUNY Upstate Medical University - Regional Oncology Center
Syracuse, New York, 13210, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Regional Cancer Care
Durham, North Carolina, 27704, United States
Cancer Centers of North Carolina (Main)
Raleigh, North Carolina, 27607, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Greater Dayton Cancer Center (Main)
Kettering, Ohio, 45409, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center (Main)
Eugene, Oregon, 97401-8122, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Thomas Jefferson Memorial Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232, United States
Cancer Centers of the Carolinas (Main)
Greenville, South Carolina, 29615, United States
The Sarah Cannon Research Institute/TN Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology, P.A.
Amarillo, Texas, 79106, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78463, United States
Texas Cancer Center at Medical City (Main)
Dallas, Texas, 75230-2510, United States
Texas Oncology, P.A. (Main)
Dallas, Texas, 75246, United States
West Texas Cancer Center-Texas Oncology
Odessa, Texas, 79761, United States
Texas Oncology, P.A.
Webster, Texas, 77598-4420, United States
Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Fairfax Northern Virginia Hematology/Oncology
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24019, United States
Northwest Cancer Specialists - Vancouver (Main)
Vancouver, Washington, 98684, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
New South Wales Southern Medical Day Care Centre
Wollongong, New South Wales, 2500, Australia
The Princess Alexandra Hospital, Dept of Respiratory Medicine
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville South, SA 5011, Australia
Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten
Linz, 4020, Austria
Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
Vienna, 1090, Austria
Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
Vienna, 1130, Austria
Klinikum Weis-Grieskirchen GmbH
Wels, 4600, Austria
UZ Brussel, Medical Oncology and Hematology
Brussels, 1090, Belgium
Centre Hospitalier Notre-Dame et Reine Fabiola
Charleroi, 6000, Belgium
Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases
Edegem, 2650, Belgium
UZ Gasthuisberg, UZ Leuven
Leuven, 3000, Belgium
C.H.U. Sart-Tilman
Liège, 4000, Belgium
III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
Plovdiv, 4004, Bulgaria
DDOncDIU Sofia District
Sofia, 1233, Bulgaria
MHAT "Tsaritsa Yoanna"
Sofia, 1504, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna, 9010, Bulgaria
Fraser Valley Cancer Centre-Surrey Memorial Hospital
Surrey, British Columbia, Canada
London Regional Cancer Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Fakultni Nemocnice Ostrava
Ostrava-Poruba, Czechia
Fakultní Thomayerova nemocnice s poliklinikou
Prague, 140 59, Czechia
Faculty Hospital Motol
Prague, 15006, Czechia
Masarykova nemocnice v Ústí nad Labem
Ústí nad Labem, 401 13, Czechia
Rikshospitalet, Finsen Center
Copenhagen, 2100, Denmark
Herlev Hospital, Onkologisk afdeling R
Herlev, 2730, Denmark
Odense Universitetshospital,Onkologisk afdeling R
Odense C, 5000, Denmark
Centre François Baclesse
Caen, 14076, France
Hôpital de la Croix-Rousse
Lyon, 69317, France
CHU Montpellier - Unité de Cancérologie Thoracique
Montpellier, 34295, France
Institut Gustave Roussy
Villejuif, 94805, France
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Charité Universitätsmedizin Berlin
Berlin, 12200, Germany
Universitätsklinikum Essen Innere Klinik und Poliklinik
Essen, 45122, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131, Germany
Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
Großhansdorf, 22927, Germany
Staedtisches Krankenhaus Martha-Maria Halle-Doelau
Halle, 6120, Germany
Thoraxklinik am Universitätsklinikum Heidelberg AG
Heidelberg, 69126, Germany
St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie
Karlsruhe, 76137, Germany
Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus
Mainz, 55131, Germany
Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie
Mannheim, 68167, Germany
Semmelweis University of Medicine
Budapest, 1125, Hungary
Országos Korányi Tbc és Pulmonológiai Intézet
Budapest, 1529, Hungary
DEODEC
Debrecen, 4032, Hungary
Matrai Gyogyintezet
Mátraháza, 3233, Hungary
County Hospital Baranya
Pécs, 7623, Hungary
Erzsébet Hospital Sopron
Sopron, 9400, Hungary
Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology
Modena, 41100, Italy
Ospedale S. Maria della Misericordia
Perugia, 06132, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00151, Italy
Ospedale S.S. Trinita
Sora, 03039, Italy
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX, Netherlands
VU University Medical Center Amsterdam
Amsterdam, 1081 HV, Netherlands
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Elkerliek Ziekenhuis, Locatie Helmond
Helmond, 5700 AB, Netherlands
Erasmus MC - Daniel den Hoed
Rotterdam, 3075 EA, Netherlands
Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
Bystra, 43-360, Poland
Akademickie Centrum Kliniczne
Gdansk, 80-211, Poland
Zespol nr 1 Szpitala im. St. Leszczynskiego
Katowice, 40-074, Poland
Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
Krakow, 31-115, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, 60-569, Poland
Szpital Specjalistyczny w Prabutach
Prabuty, 82550, Poland
Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim
Wodzisław Śląski, 44-300, Poland
Hospital Universitario Germans Trias i Pujol
Barcelona, 08916, Spain
Duran i Reynals Institut Catala d'Oncologia
L'Hospitalet de Llobregat, 08907, Spain
Fundación Jiménez Díaz. Universidad Autónoma de Madrid
Madrid, 28040, Spain
Hospital Universitario Virgin de la Victoria
Málaga, 29010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Kantonsspital Aarau
Aarau, 5011, Switzerland
Kantonsspital Graubünden
Chur, 7000, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, SM2 5PT, United Kingdom
Related Publications (1)
von Pawel J, Jotte R, Spigel DR, O'Brien ME, Socinski MA, Mezger J, Steins M, Bosquee L, Bubis J, Nackaerts K, Trigo JM, Clingan P, Schutte W, Lorigan P, Reck M, Domine M, Shepherd FA, Li S, Renschler MF. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014 Dec 10;32(35):4012-9. doi: 10.1200/JCO.2013.54.5392. Epub 2014 Nov 10.
PMID: 25385727BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Markus Renschler, M.D.
Celgene Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2007
First Posted
October 22, 2007
Study Start
September 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 6, 2019
Record last verified: 2019-10