Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00547651




Registration number
NCT00547651
Ethics application status
Date submitted
18/10/2007
Date registered
22/10/2007
Date last updated
6/11/2019

Titles & IDs
Public title
AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Scientific 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
Secondary ID [1] 0 0
AMR PH GL 2007 CL001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amrubicin
Treatment: Drugs - Topotecan

Experimental: Amrubicin - Amrubicin

Active comparator: Topotecan - Topotecan


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Until death from any cause
Secondary outcome [1] 0 0
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate
Timepoint [1] 0 0
Until death
Secondary outcome [2] 0 0
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.
Timepoint [2] 0 0
Until death
Secondary outcome [3] 0 0
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response
Timepoint [3] 0 0
Until death
Secondary outcome [4] 0 0
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression
Timepoint [4] 0 0
Until death
Secondary outcome [5] 0 0
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety
Timepoint [5] 0 0
Until death
Secondary outcome [6] 0 0
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life
Timepoint [6] 0 0
Until death

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
637
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
New South Wales Southern Medical Day Care Centre - Wollongong
Recruitment hospital [3] 0 0
The Princess Alexandra Hospital, Dept of Respiratory Medicine - Woolloongabba
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
SA 5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Austria
State/province [30] 0 0
Linz
Country [31] 0 0
Austria
State/province [31] 0 0
Wels
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Belgium
State/province [33] 0 0
Brussel
Country [34] 0 0
Belgium
State/province [34] 0 0
Charleroi
Country [35] 0 0
Belgium
State/province [35] 0 0
Edegem
Country [36] 0 0
Belgium
State/province [36] 0 0
Leuven
Country [37] 0 0
Belgium
State/province [37] 0 0
Liege
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Plovdiv
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sofia
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Varna
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Czechia
State/province [44] 0 0
Ostrava-Poruba
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 5
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha
Country [47] 0 0
Czechia
State/province [47] 0 0
Ústí nad Labem
Country [48] 0 0
Denmark
State/province [48] 0 0
Copenhagen
Country [49] 0 0
Denmark
State/province [49] 0 0
Herlev
Country [50] 0 0
Denmark
State/province [50] 0 0
Odense C
Country [51] 0 0
France
State/province [51] 0 0
Caen Cedex 5
Country [52] 0 0
France
State/province [52] 0 0
Lyon Cedex 04
Country [53] 0 0
France
State/province [53] 0 0
Montpellier Cedex
Country [54] 0 0
France
State/province [54] 0 0
Villejuif
Country [55] 0 0
Germany
State/province [55] 0 0
Bad Berka
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Essen
Country [58] 0 0
Germany
State/province [58] 0 0
Gauting
Country [59] 0 0
Germany
State/province [59] 0 0
Grosshansdorf
Country [60] 0 0
Germany
State/province [60] 0 0
Halle (Saale)
Country [61] 0 0
Germany
State/province [61] 0 0
Heidelberg
Country [62] 0 0
Germany
State/province [62] 0 0
Karlsruhe
Country [63] 0 0
Germany
State/province [63] 0 0
Mainz
Country [64] 0 0
Germany
State/province [64] 0 0
Mannheim
Country [65] 0 0
Hungary
State/province [65] 0 0
Budapest
Country [66] 0 0
Hungary
State/province [66] 0 0
Debrecen
Country [67] 0 0
Hungary
State/province [67] 0 0
Matrahaza
Country [68] 0 0
Hungary
State/province [68] 0 0
Pecs
Country [69] 0 0
Hungary
State/province [69] 0 0
Sopron
Country [70] 0 0
Italy
State/province [70] 0 0
Modena
Country [71] 0 0
Italy
State/province [71] 0 0
Perugia
Country [72] 0 0
Italy
State/province [72] 0 0
Roma
Country [73] 0 0
Italy
State/province [73] 0 0
Sora
Country [74] 0 0
Netherlands
State/province [74] 0 0
Amsterdam
Country [75] 0 0
Netherlands
State/province [75] 0 0
Groningen
Country [76] 0 0
Netherlands
State/province [76] 0 0
Helmond
Country [77] 0 0
Netherlands
State/province [77] 0 0
Rotterdam
Country [78] 0 0
Poland
State/province [78] 0 0
Bystra
Country [79] 0 0
Poland
State/province [79] 0 0
Gdansk
Country [80] 0 0
Poland
State/province [80] 0 0
Katowice
Country [81] 0 0
Poland
State/province [81] 0 0
Kraków
Country [82] 0 0
Poland
State/province [82] 0 0
Lublin
Country [83] 0 0
Poland
State/province [83] 0 0
Poznan
Country [84] 0 0
Poland
State/province [84] 0 0
Prabuty
Country [85] 0 0
Poland
State/province [85] 0 0
Wodzislaw Slaski
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
L'Hospitalet de Llobregat
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Malaga
Country [90] 0 0
Spain
State/province [90] 0 0
Valencia
Country [91] 0 0
Switzerland
State/province [91] 0 0
Aarau
Country [92] 0 0
Switzerland
State/province [92] 0 0
Chur
Country [93] 0 0
Switzerland
State/province [93] 0 0
Zurich
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Edinburgh
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Glasgow
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Manchester
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Renschler, M.D.
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00547651