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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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Chur
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Glasgow
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Manchester
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Surrey

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00547651
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00547651