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

October 30, 2019 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

637

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topotecan
Drug: Topotecan
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
Other Names:
  • Hycamtin
  • Topotecan hydrochloride
Experimental: Amrubicin
Drug: Amrubicin
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
Other Names:
  • Calsed
  • amrubidin hydrochloride
  • CNF3140

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Until death from any cause

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Markus Renschler, M.D., Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMR PH GL 2007 CL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Cell Lung Cancer

Clinical Trials on Amrubicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe