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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00932451
Registration number
NCT00932451
Ethics application status
Date submitted
30/06/2009
Date registered
3/07/2009
Date last updated
13/01/2017
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
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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
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Secondary ID [1]
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2009-012504-13
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Secondary ID [2]
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A8081005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-02341066
Experimental: PF-0231066 -
Treatment: Drugs: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate
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Assessment method [1]
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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.
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Timepoint [1]
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6 years
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Primary outcome [2]
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Percentage of Participants With Adverse Events
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Assessment method [2]
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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).
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Timepoint [2]
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6 years
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Secondary outcome [1]
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Duration of Response (DR)
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Assessment method [1]
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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.
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Timepoint [1]
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6 years
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Secondary outcome [2]
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Time to Tumor Response (TTR)
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Assessment method [2]
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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.
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Timepoint [2]
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6 years
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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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.
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Timepoint [3]
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6 years
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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6 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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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.
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Timepoint [5]
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6 years
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Secondary outcome [6]
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Probability of Survival
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Assessment method [6]
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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.
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Timepoint [6]
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6 years
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Secondary outcome [7]
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Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182
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Assessment method [7]
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Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.
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Timepoint [7]
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6 years
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Secondary outcome [8]
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Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)
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Assessment method [8]
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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.
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Timepoint [8]
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6 years
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Secondary outcome [9]
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Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)
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Assessment method [9]
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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.
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Timepoint [9]
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6 years
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Secondary outcome [10]
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QTc Prolongation in Participants
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Assessment method [10]
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The percentage of participants with maximum post-dose QTcF/QTcB (\<450, 450 - \<480, 480 - \<500, and =500 msec) were evaluated.
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Timepoint [10]
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6 years
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Secondary outcome [11]
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Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.
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Assessment method [11]
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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.
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Timepoint [11]
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6 years
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Secondary outcome [12]
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Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores
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Assessment method [12]
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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.
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Timepoint [12]
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6 years
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Secondary outcome [13]
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Mean Change From Baseline of QLQ-LC13 Scale Scores
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Assessment method [13]
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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.
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Timepoint [13]
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6 years
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Secondary outcome [14]
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Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)
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Assessment method [14]
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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.
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Timepoint [14]
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6 years
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Secondary outcome [15]
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Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale
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Assessment method [15]
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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.
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Timepoint [15]
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6 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
1069
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Royal Adelaide Hospital, Department of Medical Oncology - Adelaide
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology - East Melbourne
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Recruitment hospital [4]
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Department of Medical Oncology - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Indiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Hampshire
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New Mexico
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New York
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North Carolina
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South Carolina
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Tennessee
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Texas
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Washington
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Brazil
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Brazil
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RJ
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Brazil
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RS
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Brazil
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Sao Paulo
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Brazil
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SP
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Bulgaria
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Sofia
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Varna
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New Brunswick
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Ontario
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Guangdong
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Jiangsu
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China
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Beijing
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China
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Guangzhou
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China
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Caen Cedex 05
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France
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Dijon
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Grenoble Cedex 09
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Marseille Cedex 20
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France
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NICE Cedex 2
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France
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Paris cedex 20
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France
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Paris
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St Herblain Cedex
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France
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Villejuif
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Essen
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Germany
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Grosshansdorf
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Heidelberg
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Koeln
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Oldenburg
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Crete
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Thessaloniki
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Greece
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Athens
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Pokfulam
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Hong Kong
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Shatin, New Territories
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Hong Kong
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Tuen Mun, New Territories
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Farkasgyepu
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Hungary
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Szekesfehervar
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Hungary
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Torokbalint
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Dublin
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Avellino
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Italy
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Firenze
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Italy
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Genova
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Italy
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Lido di Camaiore (LU)
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Italy
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Lucca
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Italy
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Milano
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Italy
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Monza
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Italy
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Orbassano (TO)
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Italy
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Perugia
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Italy
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Roma
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Italy
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Torino
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Japan
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Aichi
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Hokkaido
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Hyogo
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Osaka
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Shizuoka
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Fukuoka
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Kashiwa
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Japan
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Okayama
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Korea, Republic of
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Seoul
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Russian Federation
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Galicia
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Madrid
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Pamplona
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Spain
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Spain
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Taipei
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United Kingdom
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Oxford
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Surrey
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Eastleigh
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London
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United Kingdom
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Manchester
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United Kingdom
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Southampton
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Funding & Sponsors
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Commercial sector/industry
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Name
Pfizer
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00932451
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Trial related presentations / publications
Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26. Blackhall F, Ross Camidge D, Shaw AT, Soria JC, Solomon BJ, Mok T, Hirsh V, Janne PA, Shi Y, Yang PC, Pas T, Hida T, Carpeno JC, Lanzalone S, Polli A, Iyer S, Reisman A, Wilner KD, Kim DW. Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer. ESMO Open. 2017 Aug 17;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. eCollection 2017. Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14. Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crino L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26. Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326. Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00932451
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