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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00932451




Registration number
NCT00932451
Ethics application status
Date submitted
30/06/2009
Date registered
2/07/2009
Date last updated
17/11/2016

Titles & IDs
Public title
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Scientific title
Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Secondary ID [1] 0 0
2009-012504-13
Secondary ID [2] 0 0
A8081005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Carcinoma, Non-Small-Cell Lung 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 - PF-02341066
Treatment: Drugs - PF-02341066

Experimental: PF-0231066 -

Experimental: PF-0231066 -


Treatment: Drugs: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule

Treatment: Drugs: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule

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

Outcomes
Primary outcome [1] 0 0
Objective Response Rate - The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.
Timepoint [1] 0 0
6 years
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events - Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).
Timepoint [2] 0 0
6 years
Primary outcome [3] 0 0
Objective Response Rate - The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.
Timepoint [3] 0 0
6 years
Primary outcome [4] 0 0
Percentage of Participants With Adverse Events - Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).
Timepoint [4] 0 0
6 years
Secondary outcome [1] 0 0
Duration of Response (DR) - DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4.
Timepoint [1] 0 0
6 years
Secondary outcome [2] 0 0
Time to Tumor Response (TTR) - TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR) - DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.
Timepoint [3] 0 0
6 years
Secondary outcome [4] 0 0
Progression Free Survival (PFS) - PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.
Timepoint [4] 0 0
6 years
Secondary outcome [5] 0 0
Overall Survival (OS) - OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4.
Timepoint [5] 0 0
6 years
Secondary outcome [6] 0 0
Probability of Survival - Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.
Timepoint [6] 0 0
6 years
Secondary outcome [7] 0 0
Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182 - Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.
Timepoint [7] 0 0
6 years
Secondary outcome [8] 0 0
Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) - Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.
Timepoint [8] 0 0
6 years
Secondary outcome [9] 0 0
Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population) - The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of =1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of =1xULN.
Timepoint [9] 0 0
6 years
Secondary outcome [10] 0 0
QTc Prolongation in Participants - The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and =500 msec) were evaluated.
Timepoint [10] 0 0
6 years
Secondary outcome [11] 0 0
Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores. - The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Timepoint [11] 0 0
6 years
Secondary outcome [12] 0 0
Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores - The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Timepoint [12] 0 0
6 years
Secondary outcome [13] 0 0
Mean Change From Baseline of QLQ-LC13 Scale Scores - The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Timepoint [13] 0 0
6 years
Secondary outcome [14] 0 0
Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK) - The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.
Timepoint [14] 0 0
6 years
Secondary outcome [15] 0 0
Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale - The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.
Timepoint [15] 0 0
6 years
Secondary outcome [16] 0 0
Duration of Response (DR) - DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4.
Timepoint [16] 0 0
6 years
Secondary outcome [17] 0 0
Time to Tumor Response (TTR) - TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.
Timepoint [17] 0 0
6 years
Secondary outcome [18] 0 0
Disease Control Rate (DCR) - DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.
Timepoint [18] 0 0
6 years
Secondary outcome [19] 0 0
Progression Free Survival (PFS) - PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.
Timepoint [19] 0 0
6 years
Secondary outcome [20] 0 0
Overall Survival (OS) - OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4.
Timepoint [20] 0 0
6 years
Secondary outcome [21] 0 0
Probability of Survival - Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.
Timepoint [21] 0 0
6 years
Secondary outcome [22] 0 0
Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182 - Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.
Timepoint [22] 0 0
6 years
Secondary outcome [23] 0 0
Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) - Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.
Timepoint [23] 0 0
6 years
Secondary outcome [24] 0 0
Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population) - The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of =1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of =1xULN.
Timepoint [24] 0 0
6 years
Secondary outcome [25] 0 0
QTc Prolongation in Participants - The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and =500 msec) were evaluated.
Timepoint [25] 0 0
6 years
Secondary outcome [26] 0 0
Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores. - The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Timepoint [26] 0 0
6 years
Secondary outcome [27] 0 0
Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores - The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Timepoint [27] 0 0
6 years
Secondary outcome [28] 0 0
Mean Change From Baseline of QLQ-LC13 Scale Scores - The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.
Timepoint [28] 0 0
6 years
Secondary outcome [29] 0 0
Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK) - The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.
Timepoint [29] 0 0
6 years
Secondary outcome [30] 0 0
Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale - The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.
Timepoint [30] 0 0
6 years

Eligibility
Key inclusion criteria
- histologically or cytologically proven diagnosis of non-small cell lung cancer

- positive for the ALK fusion gene (test provided by either a central laboratory. Local
laboratory may be used for certain cases)

- may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and
discontinued treatment due to Response Evaluation Criterion in Solid Tumors
(RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been
analyzed and the results made available, at any time without RECIST-defined
progression.

- Tumors can be measurable or non measurable
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- prior treatment with PF-02341066

- received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor,
for advanced non-small cell lung cancer

- current enrollment in another therapeutic clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other design features
Phase
Phase 2
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,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Royal Adelaide Hospital, Department of Medical Oncology - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology - East Melbourne
Recruitment hospital [4] 0 0
Department of Medical Oncology - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
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
Arkansas
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
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
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
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
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
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
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
Washington
Country [28] 0 0
Brazil
State/province [28] 0 0
Bahia
Country [29] 0 0
Brazil
State/province [29] 0 0
RJ
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
SP
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Sofia
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Varna
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
New Brunswick
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
State/province [40] 0 0
Jiangsu
Country [41] 0 0
China
State/province [41] 0 0
Beijing
Country [42] 0 0
China
State/province [42] 0 0
Guangzhou
Country [43] 0 0
China
State/province [43] 0 0
Shanghai
Country [44] 0 0
France
State/province [44] 0 0
Caen Cedex 05
Country [45] 0 0
France
State/province [45] 0 0
Dijon
Country [46] 0 0
France
State/province [46] 0 0
Grenoble Cedex 09
Country [47] 0 0
France
State/province [47] 0 0
Marseille Cedex 20
Country [48] 0 0
France
State/province [48] 0 0
NICE Cedex 2
Country [49] 0 0
France
State/province [49] 0 0
Paris cedex 20
Country [50] 0 0
France
State/province [50] 0 0
Paris
Country [51] 0 0
France
State/province [51] 0 0
St Herblain Cedex
Country [52] 0 0
France
State/province [52] 0 0
Villejuif
Country [53] 0 0
Germany
State/province [53] 0 0
Dresden
Country [54] 0 0
Germany
State/province [54] 0 0
Essen
Country [55] 0 0
Germany
State/province [55] 0 0
Grosshansdorf
Country [56] 0 0
Germany
State/province [56] 0 0
Hamburg
Country [57] 0 0
Germany
State/province [57] 0 0
Heidelberg
Country [58] 0 0
Germany
State/province [58] 0 0
Koeln
Country [59] 0 0
Germany
State/province [59] 0 0
Muenchen
Country [60] 0 0
Germany
State/province [60] 0 0
Oldenburg
Country [61] 0 0
Germany
State/province [61] 0 0
Wiesbaden
Country [62] 0 0
Greece
State/province [62] 0 0
Crete
Country [63] 0 0
Greece
State/province [63] 0 0
Thessaloniki
Country [64] 0 0
Greece
State/province [64] 0 0
Athens
Country [65] 0 0
Hong Kong
State/province [65] 0 0
Pokfulam
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Shatin, New Territories
Country [67] 0 0
Hong Kong
State/province [67] 0 0
Tuen Mun, New Territories
Country [68] 0 0
Hungary
State/province [68] 0 0
Budapest
Country [69] 0 0
Hungary
State/province [69] 0 0
Debrecen
Country [70] 0 0
Hungary
State/province [70] 0 0
Farkasgyepu
Country [71] 0 0
Hungary
State/province [71] 0 0
Szekesfehervar
Country [72] 0 0
Hungary
State/province [72] 0 0
Torokbalint
Country [73] 0 0
Ireland
State/province [73] 0 0
Dublin
Country [74] 0 0
Ireland
State/province [74] 0 0
Galway
Country [75] 0 0
Italy
State/province [75] 0 0
Avellino
Country [76] 0 0
Italy
State/province [76] 0 0
Firenze
Country [77] 0 0
Italy
State/province [77] 0 0
Genova
Country [78] 0 0
Italy
State/province [78] 0 0
Lido di Camaiore (LU)
Country [79] 0 0
Italy
State/province [79] 0 0
Lucca
Country [80] 0 0
Italy
State/province [80] 0 0
Milano
Country [81] 0 0
Italy
State/province [81] 0 0
Monza
Country [82] 0 0
Italy
State/province [82] 0 0
Orbassano (TO)
Country [83] 0 0
Italy
State/province [83] 0 0
Perugia
Country [84] 0 0
Italy
State/province [84] 0 0
Roma
Country [85] 0 0
Italy
State/province [85] 0 0
Torino
Country [86] 0 0
Japan
State/province [86] 0 0
Aichi
Country [87] 0 0
Japan
State/province [87] 0 0
Hokkaido
Country [88] 0 0
Japan
State/province [88] 0 0
Hyogo
Country [89] 0 0
Japan
State/province [89] 0 0
Osaka
Country [90] 0 0
Japan
State/province [90] 0 0
Shizuoka
Country [91] 0 0
Japan
State/province [91] 0 0
Tokyo
Country [92] 0 0
Japan
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Japan
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Japan
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Groningen
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Gdansk
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Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients
with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene.
This trial will also allow patients from a Phase 3 trial who received standard of care
chemotherapy (Study A8081007) to receive PF-02341066.
Trial website
https://clinicaltrials.gov/show/NCT00932451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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