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/show/NCT00364351




Registration number
NCT00364351
Ethics application status
Date submitted
14/08/2006
Date registered
15/08/2006
Date last updated
25/01/2018

Titles & IDs
Public title
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
Scientific title
A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactimaâ„¢ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy
Secondary ID [1] 0 0
EUDRACT No. 2006-000259-16
Secondary ID [2] 0 0
D4200C00057
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 - Vandetanib
Treatment: Drugs - Erlotinib

Active Comparator: 1 - Erlotinib

Experimental: 2 - Vandetanib


Treatment: Drugs: Vandetanib
once daily oral tablet

Treatment: Drugs: Erlotinib
oral dose

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) - Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.
Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Timepoint [1] 0 0
progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Timepoint [1] 0 0
Time to death in months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) - The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
Timepoint [2] 0 0
RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR) - Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.
Timepoint [3] 0 0
RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression
Secondary outcome [4] 0 0
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain - Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30.
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days.
Timepoint [4] 0 0
Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
Secondary outcome [5] 0 0
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea - Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days.
Timepoint [5] 0 0
Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
Secondary outcome [6] 0 0
Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough - Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).
Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days.
Timepoint [6] 0 0
Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit

Eligibility
Key inclusion criteria
- Confirmed locally advanced or metastatic NSCLC

- Failure of at least one but not more than two prior chemotherapy regimens
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent),
sorafenib (Nexavar)

- Chemotherapy or other type of anti cancer therapy within 4 weeks of study start

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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)
Recruitment hospital [1] 0 0
Research Site - Ashford
Recruitment hospital [2] 0 0
Research Site - Bedford Park
Recruitment hospital [3] 0 0
Research Site - Chermside
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Hornsby
Recruitment hospital [6] 0 0
Research Site - Kogarah
Recruitment hospital [7] 0 0
Research Site - Malvern
Recruitment hospital [8] 0 0
Research Site - Prahran
Recruitment hospital [9] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
- Ashford
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Geelong
Recruitment postcode(s) [5] 0 0
- Hornsby
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Prahran
Recruitment postcode(s) [9] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
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
South Carolina
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
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad de Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Córdoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Gonnet
Country [19] 0 0
Argentina
State/province [19] 0 0
Ramos Mejía
Country [20] 0 0
Argentina
State/province [20] 0 0
Rosario
Country [21] 0 0
Argentina
State/province [21] 0 0
Santa Fe
Country [22] 0 0
Brazil
State/province [22] 0 0
Belo Horizonte
Country [23] 0 0
Brazil
State/province [23] 0 0
Caxias do Sul
Country [24] 0 0
Brazil
State/province [24] 0 0
Curitiba
Country [25] 0 0
Brazil
State/province [25] 0 0
Goiânia
Country [26] 0 0
Brazil
State/province [26] 0 0
Porto Alegre
Country [27] 0 0
Brazil
State/province [27] 0 0
Santo André
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
Country [30] 0 0
Canada
State/province [30] 0 0
Manitoba
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Prince Edward Island
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
China
State/province [34] 0 0
Beijing
Country [35] 0 0
China
State/province [35] 0 0
Dalian
Country [36] 0 0
China
State/province [36] 0 0
Hangzhou
Country [37] 0 0
China
State/province [37] 0 0
Nanjing
Country [38] 0 0
China
State/province [38] 0 0
Nanning
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
China
State/province [40] 0 0
Shenyang
Country [41] 0 0
China
State/province [41] 0 0
Wuhan
Country [42] 0 0
Denmark
State/province [42] 0 0
Herlev
Country [43] 0 0
Denmark
State/province [43] 0 0
København Ø
Country [44] 0 0
Denmark
State/province [44] 0 0
Næstved
Country [45] 0 0
France
State/province [45] 0 0
Caen
Country [46] 0 0
France
State/province [46] 0 0
Clermont Ferrand
Country [47] 0 0
France
State/province [47] 0 0
Marseille
Country [48] 0 0
France
State/province [48] 0 0
Paris Cedex 12
Country [49] 0 0
France
State/province [49] 0 0
RENNES Cedex 9
Country [50] 0 0
France
State/province [50] 0 0
Vesoul Cedex
Country [51] 0 0
Germany
State/province [51] 0 0
Großhansdorf
Country [52] 0 0
Germany
State/province [52] 0 0
Göttingen
Country [53] 0 0
Germany
State/province [53] 0 0
Hannover
Country [54] 0 0
Germany
State/province [54] 0 0
Heidelberg
Country [55] 0 0
Germany
State/province [55] 0 0
Karlsruhe
Country [56] 0 0
Germany
State/province [56] 0 0
Löwenstein
Country [57] 0 0
Germany
State/province [57] 0 0
Mainz
Country [58] 0 0
Germany
State/province [58] 0 0
Mönchengladbach
Country [59] 0 0
Germany
State/province [59] 0 0
Ulm
Country [60] 0 0
Hong Kong
State/province [60] 0 0
Hong Kong
Country [61] 0 0
India
State/province [61] 0 0
Bangalore
Country [62] 0 0
India
State/province [62] 0 0
Karnataka
Country [63] 0 0
India
State/province [63] 0 0
New Delhi
Country [64] 0 0
India
State/province [64] 0 0
Pune
Country [65] 0 0
India
State/province [65] 0 0
Trivandrum
Country [66] 0 0
Indonesia
State/province [66] 0 0
Bandung
Country [67] 0 0
Indonesia
State/province [67] 0 0
Jakarta
Country [68] 0 0
Indonesia
State/province [68] 0 0
Solo
Country [69] 0 0
Italy
State/province [69] 0 0
Ancona
Country [70] 0 0
Italy
State/province [70] 0 0
Avellino
Country [71] 0 0
Italy
State/province [71] 0 0
Catania
Country [72] 0 0
Italy
State/province [72] 0 0
Genova
Country [73] 0 0
Italy
State/province [73] 0 0
Mantova
Country [74] 0 0
Italy
State/province [74] 0 0
Milano
Country [75] 0 0
Italy
State/province [75] 0 0
Orbassano
Country [76] 0 0
Italy
State/province [76] 0 0
Parma
Country [77] 0 0
Italy
State/province [77] 0 0
Perugia
Country [78] 0 0
Italy
State/province [78] 0 0
Roma
Country [79] 0 0
Italy
State/province [79] 0 0
Rozzano
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seoul
Country [81] 0 0
Mexico
State/province [81] 0 0
Juchitan
Country [82] 0 0
Mexico
State/province [82] 0 0
Monterrey
Country [83] 0 0
Mexico
State/province [83] 0 0
Morelia
Country [84] 0 0
Mexico
State/province [84] 0 0
Puebla
Country [85] 0 0
Mexico
State/province [85] 0 0
Saltillo
Country [86] 0 0
Mexico
State/province [86] 0 0
Zacatecas
Country [87] 0 0
Netherlands
State/province [87] 0 0
Harderwijk
Country [88] 0 0
Netherlands
State/province [88] 0 0
Nieuwegein
Country [89] 0 0
Netherlands
State/province [89] 0 0
Rotterdam
Country [90] 0 0
Netherlands
State/province [90] 0 0
Zwolle
Country [91] 0 0
Norway
State/province [91] 0 0
Bergen
Country [92] 0 0
Norway
State/province [92] 0 0
Haugesund
Country [93] 0 0
Norway
State/province [93] 0 0
Kristiansand
Country [94] 0 0
Norway
State/province [94] 0 0
Oslo
Country [95] 0 0
Norway
State/province [95] 0 0
Stavanger
Country [96] 0 0
Norway
State/province [96] 0 0
Tromsø
Country [97] 0 0
Norway
State/province [97] 0 0
Trondheim
Country [98] 0 0
Philippines
State/province [98] 0 0
Cebu City
Country [99] 0 0
Philippines
State/province [99] 0 0
Davao City
Country [100] 0 0
Philippines
State/province [100] 0 0
Manila
Country [101] 0 0
Philippines
State/province [101] 0 0
Pasay City
Country [102] 0 0
Philippines
State/province [102] 0 0
Quezon City
Country [103] 0 0
Spain
State/province [103] 0 0
Elche(Alicante)
Country [104] 0 0
Spain
State/province [104] 0 0
Jaén
Country [105] 0 0
Spain
State/province [105] 0 0
Madrid
Country [106] 0 0
Spain
State/province [106] 0 0
Mataró(Barcelona)
Country [107] 0 0
Spain
State/province [107] 0 0
Málaga
Country [108] 0 0
Spain
State/province [108] 0 0
Pamplona
Country [109] 0 0
Taiwan
State/province [109] 0 0
Taichung
Country [110] 0 0
Taiwan
State/province [110] 0 0
Tainan
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taipei
Country [112] 0 0
Taiwan
State/province [112] 0 0
Tao-Yuan
Country [113] 0 0
Thailand
State/province [113] 0 0
Bangkok
Country [114] 0 0
Thailand
State/province [114] 0 0
Chiang Mai
Country [115] 0 0
Thailand
State/province [115] 0 0
Lampang
Country [116] 0 0
Thailand
State/province [116] 0 0
Songkla
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Birmingham
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Cambridge
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Leicester
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Liverpool
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Nottingham
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Sheffield
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung
Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy,
Erlotinib
Trial website
https://clinicaltrials.gov/show/NCT00364351
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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
Other publications