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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/NCT00050973




Registration number
NCT00050973
Ethics application status
Date submitted
31/12/2002
Date registered
3/01/2003
Date last updated
14/05/2013

Titles & IDs
Public title
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Scientific title
Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
L1069-49
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-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 - bexarotene

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

Outcomes

Eligibility
Key inclusion criteria
Patients must have:

- Pathologic (histologic or cytologic) confirmation of NSCLC

- Stage IIIB with malignant pleural effusion or Stage IV disease

- At least one measurable or evaluable NSCLC lesion that has not been previously
irradiated unless radiation therapy was more than three weeks prior to entry in the
study and the lesion has been shown to have progressed subsequent to the radiation
therapy

- ECOG performance status 0 or 1

- Adequate organ system function

- Fasting serum triglycerides that are within the age-adjusted normal range (or
normalized with appropriate intervention such as antilipid therapy prior to the
initiation of Targretin capsule therapy).

Patients must be able to complete at least four cycles of combination chemotherapy (i.e.,
approximately four months)

Patients must not have had:

- Brain metastasis

- Prior chemotherapy for NSCLC

- Prior platinum-based chemotherapy for any indication
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
1/03/2005
Sample size
Target
Accrual to date
Final
623
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [3] 0 0
Southern Medical Daycare Centre - Wollongong
Recruitment hospital [4] 0 0
Burnside War Memorial Hospital - Toorak Gardens
Recruitment hospital [5] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Border Medical Oncology - Wodonga
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [5] 0 0
5011 - Woodville
Recruitment postcode(s) [6] 0 0
7001 - Hobart
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3690 - Wodonga
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
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Manitoba
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Ceske Budejovice
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Praha-6-Veleslavin
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Praha-8
Country [21] 0 0
France
State/province [21] 0 0
Cedex
Country [22] 0 0
Greece
State/province [22] 0 0
Alexandroupolis
Country [23] 0 0
Greece
State/province [23] 0 0
Crete
Country [24] 0 0
Greece
State/province [24] 0 0
Thessaloniki
Country [25] 0 0
Greece
State/province [25] 0 0
Athens
Country [26] 0 0
Greece
State/province [26] 0 0
Rio
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Deszk
Country [29] 0 0
Israel
State/province [29] 0 0
Ashkelon
Country [30] 0 0
Israel
State/province [30] 0 0
Jerusalem
Country [31] 0 0
Israel
State/province [31] 0 0
Kfar Sava
Country [32] 0 0
Israel
State/province [32] 0 0
Rehovot
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Aviv
Country [34] 0 0
Israel
State/province [34] 0 0
Tel Hashomer
Country [35] 0 0
Israel
State/province [35] 0 0
Zerifin
Country [36] 0 0
Poland
State/province [36] 0 0
Bialystok
Country [37] 0 0
Poland
State/province [37] 0 0
Gdansk
Country [38] 0 0
Poland
State/province [38] 0 0
Krakow
Country [39] 0 0
Poland
State/province [39] 0 0
Poznan
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Arkhangelsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Russian Federation
State/province [43] 0 0
St. Petersburg
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Aberdeen
Country [45] 0 0
United Kingdom
State/province [45] 0 0
England
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard
chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients
who have not yet received chemotherapy for their lung cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00050973
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mack Mabry, M.D.
Address 0 0
Ligand Pharmaceuticals
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/NCT00050973