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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/NCT00080340




Registration number
NCT00080340
Ethics application status
Date submitted
26/03/2004
Date registered
30/03/2004
Date last updated
15/01/2008

Titles & IDs
Public title
Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Scientific title
Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
TLK286.3020
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TLK286 (Telcyta) HCl for Injection
Treatment: Drugs - gefitinib (Iressa)

Treatment: Drugs: TLK286 (Telcyta) HCl for Injection


Treatment: Drugs: gefitinib (Iressa)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Clinical diagnosis of non-small cell lung cancer

- Non-small cell lung cancer that is not curable with surgery, radiation, or combined
modality chemoradiation

- Failed two prior chemotherapy regimens which must have included platinum

- Measurable disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with more than two prior chemotherapy regimens

- History of bone marrow transplantation or stem cell support

- Pregnant or lactating women

- Known history of prior gefitinib therapy

- Known history of prior TLK286 therapy

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Albury Base Hospital - Albury
Recruitment hospital [2] 0 0
West Albury Barker's Pharmacy - Albury
Recruitment hospital [3] 0 0
Department of Medical Oncology-Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [4] 0 0
Department Of Oncology - South Brisbane
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [7] 0 0
Pharmatel Fresenius Kabi Pty Ltd. - West Melbourne
Recruitment hospital [8] 0 0
Murray Valley Private Hospital - Wodonga
Recruitment hospital [9] 0 0
Bankstown Lidcombe Hospital - Department of Medical Oncology - Bankstown
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [12] 0 0
Royal North Shore Hospital-Medical Oncology Dept. - St. Leonards
Recruitment hospital [13] 0 0
Border Medical Oncology - Murray Valley Private Hospital - Wodonga
Recruitment hospital [14] 0 0
Clinical Trials Centre - Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5041 - Bedford Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3003 - West Melbourne
Recruitment postcode(s) [7] 0 0
3690 - Wodonga
Recruitment postcode(s) [8] 0 0
2200 - Bankstown
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
2065 - St. Leonards
Recruitment postcode(s) [12] 0 0
2500 - Wollongong
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Buenos Aires
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Mar del Plata
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Cordoba
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Rosario
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San Martin
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BA
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CE
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GO
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MG
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PR
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Las Condes
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Chile
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Santiago
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Germany
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Gauting
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Grosshansdorf
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Germany
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Hamburg
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Germany
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Karlshure
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Rohrbach BW
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Germany
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Haale
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Catania
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Mantova
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Dundee

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib
(Iressa) in the treatment of non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00080340
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00080340