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AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amrubicin
Topotecan
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, Lung Cancer, Limited Disease Sensitive Small Cell Lung Cancer, Extensive Disease Sensitive Small Cell Lung Cancer, Limited Disease Refractory Small Cell Lung Cancer, Extensive Disease Refractory Small Cell Lung Cancer, Refractory Small Cell Lung Cancer, Sensitive Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Northwest Alabama Cancer Center
  • Arizona Oncology Associates
  • Little Rock Hematology Oncology Associates
  • Cancer Care Associates of Fresno Medical Group, Inc.
  • Cedars-Sinai Outpatient Cancer Center
  • University of Colorado Health Science Centre
  • Rocky Mountain Cancer Center - Midtown (Main)
  • Advanced Medical Specialties
  • Ocala Oncology Center
  • Cancer Centers of Florida, P.A.
  • Florida Oncology Associates
  • Sacred Heart Medical Oncology
  • Medical Oncology Associates of Augusta
  • Joliet Oncology-Hematology Associates, Ltd.
  • Cancer & Hematology Specialists of Chicago (Main)
  • Illinois Cancer Care
  • Cancer Care at Blessing Hospital
  • Central Indiana Cancer Centers
  • Hope Center
  • Kansas City Cancer Center (Main)
  • Cancer Center of Kansas
  • Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC
  • Tulane University Health Sciences Center
  • Maine Center for Cancer Medicine and Blood Disorders
  • Sinai Hospital of Baltimore, Inc.
  • Center for Cancer and Blood Disorders
  • Alliance Hematology Oncology, P.A. (Main)
  • Kalamazoo Hematology and Oncology
  • Michigan Hematology & Oncology Institute
  • University of Minnesota Medical Center, Cancer Center
  • Missouri Cancer Associates
  • St. Joseph Oncology, Inc.
  • Comprehensive Care Centers of Nevada (Main)
  • New York Oncology Hematology, P.C.
  • SUNY Upstate Medical University - Regional Oncology Center
  • Lineberger Comprehensive Cancer Center
  • Regional Cancer Care
  • Cancer Centers of North Carolina (Main)
  • Piedmont Hematology Oncology Associates
  • Gabrail Cancer Center
  • Greater Dayton Cancer Center (Main)
  • Cancer Care Associates
  • Cancer Care Associates
  • Willamette Valley Cancer Center (Main)
  • Medical Oncology Associates
  • Thomas Jefferson Memorial Hospital
  • UPMC Cancer Pavilion
  • Cancer Centers of the Carolinas (Main)
  • The Sarah Cannon Research Institute/TN Oncology
  • Texas Oncology, P.A.
  • Coastal Bend Cancer Center
  • Texas Cancer Center at Medical City (Main)
  • Texas Oncology, P.A. (Main)
  • West Texas Cancer Center-Texas Oncology
  • Texas Oncology, P.A.
  • Texoma Cancer Center
  • Fairfax Northern Virginia Hematology/Oncology
  • Virginia Oncology Associates
  • Blue Ridge Cancer Care
  • Northwest Cancer Specialists - Vancouver (Main)
  • Marshfield Clinic
  • Royal North Shore Hospital
  • New South Wales Southern Medical Day Care Centre
  • The Princess Alexandra Hospital, Dept of Respiratory Medicine
  • Flinders Medical Centre
  • The Queen Elizabeth Hospital
  • Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten
  • Klinikum Weis-Grieskirchen GmbH
  • Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
  • Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
  • UZ Brussel, Medical Oncology and Hematology
  • Centre Hospitalier Notre-Dame et Reine Fabiola
  • Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases
  • UZ Gasthuisberg, UZ Leuven
  • C.H.U. Sart-Tilman
  • III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
  • DDOncDIU Sofia District
  • MHAT "Tsaritsa Yoanna"
  • University Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Fraser Valley Cancer Centre-Surrey Memorial Hospital
  • London Regional Cancer Centre
  • Princess Margaret Hospital
  • Humber River Regional Hospital
  • Royal Victoria Hospital
  • Fakultni Nemocnice Ostrava
  • Faculty Hospital Motol
  • Fakultní Thomayerova nemocnice s poliklinikou
  • Masarykova nemocnice v Ústí nad Labem
  • Rikshospitalet, Finsen Center
  • Herlev Hospital, Onkologisk afdeling R
  • Odense Universitetshospital,Onkologisk afdeling R
  • Centre François Baclesse
  • Hôpital de la Croix-Rousse
  • CHU Montpellier - Unité de Cancérologie Thoracique
  • Institut Gustave Roussy
  • Zentralklinik Bad Berka GmbH
  • Charité Universitätsmedizin Berlin
  • Universitätsklinikum Essen Innere Klinik und Poliklinik
  • Asklepios Fachkliniken Muenchen Gauting
  • Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
  • Staedtisches Krankenhaus Martha-Maria Halle-Doelau
  • Thoraxklinik am Universitätsklinikum Heidelberg AG
  • St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie
  • Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus
  • Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie
  • Semmelweis University of Medicine
  • Országos Korányi Tbc és Pulmonológiai Intézet
  • DEODEC
  • Matrai Gyogyintezet
  • County Hospital Baranya
  • Erzsébet Hospital Sopron
  • Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology
  • Ospedale S. Maria della Misericordia
  • Azienda Ospedaliera San Camillo Forlanini
  • Ospedale S.S. Trinita
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
  • VU University Medical Center Amsterdam
  • University Medical Center Groningen
  • Elkerliek Ziekenhuis, Locatie Helmond
  • Erasmus MC - Daniel den Hoed
  • Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
  • Akademickie Centrum Kliniczne
  • Zespol nr 1 Szpitala im. St. Leszczynskiego
  • Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
  • Centrum Onkologii Ziemi Lubelskiej
  • Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
  • Szpital Specjalistyczny w Prabutach
  • Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim
  • Hospital Universitario Germans Trias i Pujol
  • Duran i Reynals Institut Catala d'Oncologia
  • Fundación Jiménez Díaz. Universidad Autónoma de Madrid
  • Hospital Universitario Virgin de la Victoria
  • Hospital General Universitario de Valencia
  • Kantonsspital Aarau
  • Kantonsspital Graubünden
  • Universitätsspital Zürich
  • Edinburgh Cancer Research Centre
  • Beatson West of Scotland Cancer Centre
  • Christie Hospital NHS Foundation Trust
  • The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amrubicin

Topotecan

Arm Description

Amrubicin

Topotecan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life

Full Information

First Posted
October 18, 2007
Last Updated
October 30, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00547651
Brief Title
AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2007 (Actual)
Primary Completion Date
May 1, 2011 (Actual)
Study Completion Date
May 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Small cell lung cancer represents approximately 13% of the cancers of the lung and presents as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone (35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine differentiation. The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group system that categorizes patients as having limited or extensive disease. Limited stage SCLC is disease confined to 1 hemithorax with or without adjacent mediastinal and/or supraclavicular lymph node involvement, but without a pleural effusion. This extent of disease can be included in a tolerable radiation field. Extensive-disease SCLC is any disease beyond the definition of limited-stage disease. There are few proven treatment options for SCLC patients who fail first-line chemotherapy. New treatment strategies must be evaluated. The need to discover active agents with better toxicity profiles continues to be of great importance. Amrubicin may be an effective treatment for this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, Lung Cancer, Limited Disease Sensitive Small Cell Lung Cancer, Extensive Disease Sensitive Small Cell Lung Cancer, Limited Disease Refractory Small Cell Lung Cancer, Extensive Disease Refractory Small Cell Lung Cancer, Refractory Small Cell Lung Cancer, Sensitive Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
637 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amrubicin
Arm Type
Experimental
Arm Description
Amrubicin
Arm Title
Topotecan
Arm Type
Active Comparator
Arm Description
Topotecan
Intervention Type
Drug
Intervention Name(s)
Amrubicin
Other Intervention Name(s)
amrubidin hydrochloride, Calsed, CNF3140
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Topotecan hydrochloride, Hycamtin
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
Until death from any cause
Secondary Outcome Measure Information:
Title
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate
Time Frame
Until death
Title
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.
Time Frame
Until death
Title
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response
Time Frame
Until death
Title
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression
Time Frame
Until death
Title
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety
Time Frame
Until death
Title
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life
Time Frame
Until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Renschler, M.D.
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Alabama Cancer Center
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Little Rock Hematology Oncology Associates
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cancer Care Associates of Fresno Medical Group, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Cedars-Sinai Outpatient Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Health Science Centre
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Center - Midtown (Main)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Advanced Medical Specialties
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Cancer Centers of Florida, P.A.
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Florida Oncology Associates
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Sacred Heart Medical Oncology
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Medical Oncology Associates of Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Cancer & Hematology Specialists of Chicago (Main)
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Cancer Care at Blessing Hospital
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Hope Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Kansas City Cancer Center (Main)
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Jayne Gurtler MD, Laura Brizn MD, Angelo Russo MD, and Janet Burroff MD, APMC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sinai Hospital of Baltimore, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Alliance Hematology Oncology, P.A. (Main)
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Kalamazoo Hematology and Oncology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Michigan Hematology & Oncology Institute
City
Southgate
State/Province
Michigan
ZIP/Postal Code
48195
Country
United States
Facility Name
University of Minnesota Medical Center, Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
St. Joseph Oncology, Inc.
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Comprehensive Care Centers of Nevada (Main)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Latham
State/Province
New York
ZIP/Postal Code
12110-0610
Country
United States
Facility Name
SUNY Upstate Medical University - Regional Oncology Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Regional Cancer Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Cancer Centers of North Carolina (Main)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Piedmont Hematology Oncology Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Greater Dayton Cancer Center (Main)
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Willamette Valley Cancer Center (Main)
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
Facility Name
Medical Oncology Associates
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Thomas Jefferson Memorial Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UPMC Cancer Pavilion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Cancer Centers of the Carolinas (Main)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
The Sarah Cannon Research Institute/TN Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology, P.A.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78463
Country
United States
Facility Name
Texas Cancer Center at Medical City (Main)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-2510
Country
United States
Facility Name
Texas Oncology, P.A. (Main)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
West Texas Cancer Center-Texas Oncology
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Texas Oncology, P.A.
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4420
Country
United States
Facility Name
Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Fairfax Northern Virginia Hematology/Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24019
Country
United States
Facility Name
Northwest Cancer Specialists - Vancouver (Main)
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
New South Wales Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
The Princess Alexandra Hospital, Dept of Respiratory Medicine
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
ZIP/Postal Code
SA 5011
Country
Australia
Facility Name
Allgemeines Krankenhaus der Stadt Linz, Abteilung fur Atem und Lungenkrankheiten
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Klinikum Weis-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Allegemeines Krankenhaus Wien, Univ. Klinik fur Innere, Medizin I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Hietzing, 5 Med. Abteilung mit Onkologie
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
UZ Brussel, Medical Oncology and Hematology
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Centre Hospitalier Notre-Dame et Reine Fabiola
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen, Dept. Respiratory Diseases
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gasthuisberg, UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
C.H.U. Sart-Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
DDOncDIU Sofia District
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT "Tsaritsa Yoanna"
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveta Marina"
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Fraser Valley Cancer Centre-Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava-Poruba
Country
Czechia
Facility Name
Faculty Hospital Motol
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Fakultní Thomayerova nemocnice s poliklinikou
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Masarykova nemocnice v Ústí nad Labem
City
Ústí nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Rikshospitalet, Finsen Center
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital, Onkologisk afdeling R
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitetshospital,Onkologisk afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Centre François Baclesse
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
CHU Montpellier - Unité de Cancérologie Thoracique
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum Essen Innere Klinik und Poliklinik
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Asklepios Fachkliniken Muenchen Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Krankenhaus Grosshansdorf, Zentrum fur Pneumologie und Thoraxchirurgie
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Staedtisches Krankenhaus Martha-Maria Halle-Doelau
City
Halle (Saale)
ZIP/Postal Code
6120
Country
Germany
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg AG
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
St. Vincentius-Kliniken Karlsruhe, Hamatologie, Med Onkologie und Immunologie
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Katholisches Klinikum Mainz, St. Hildegardis Krankenhaus
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum Mannheim GmbH, Chirugische Klinik, Thorakale Onkologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Semmelweis University of Medicine
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Országos Korányi Tbc és Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
DEODEC
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Matrai Gyogyintezet
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
County Hospital Baranya
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Erzsébet Hospital Sopron
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Policlinico di Modena - University of Modena & Reggio Emilia, Dept Oncology & Hematology
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Ospedale S. Maria della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00151
Country
Italy
Facility Name
Ospedale S.S. Trinita
City
Sora
ZIP/Postal Code
03039
Country
Italy
Facility Name
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
VU University Medical Center Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Elkerliek Ziekenhuis, Locatie Helmond
City
Helmond
ZIP/Postal Code
5700 AB
Country
Netherlands
Facility Name
Erasmus MC - Daniel den Hoed
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
City
Bystra
ZIP/Postal Code
43-360
Country
Poland
Facility Name
Akademickie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Zespol nr 1 Szpitala im. St. Leszczynskiego
City
Katowice
ZIP/Postal Code
40-074
Country
Poland
Facility Name
Klinika Nowotworow Ukladowych i Uogolnionych Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie
City
Kraków
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Tarakochirurgii Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Szpital Specjalistyczny w Prabutach
City
Prabuty
ZIP/Postal Code
82550
Country
Poland
Facility Name
Wojewódzki Szpital Chorób Pluc im Alojzego Pawelca w Wodzislawiu Slaskim
City
Wodzislaw Slaski
ZIP/Postal Code
44-300
Country
Poland
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Duran i Reynals Institut Catala d'Oncologia
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Fundación Jiménez Díaz. Universidad Autónoma de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgin de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5011
Country
Switzerland
Facility Name
Kantonsspital Graubünden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Edinburgh Cancer Research Centre
City
Edinburgh
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25385727
Citation
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.
Results Reference
background

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AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

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