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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00932893
Registration number
NCT00932893
Ethics application status
Date submitted
30/06/2009
Date registered
3/07/2009
Date last updated
2/01/2017
Titles & IDs
Public title
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care 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 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
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Secondary ID [1]
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2009-012595-27
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Secondary ID [2]
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A8081007
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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
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Docetaxel
Experimental: PF-02341066 -
Active comparator: Pemetrexed or Docetaxel - Investigator selection of either pemetrexed or docetaxel as the active comparator
Treatment: Drugs: PF-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Treatment: Drugs: Pemetrexed
Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Treatment: Drugs: Docetaxel
Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle
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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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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
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Timepoint [1]
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Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.
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Timepoint [1]
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Randomization until death (up to 4.5 years)
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Secondary outcome [2]
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Overall Survival Probability at Months 6 and 12
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Assessment method [2]
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Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.
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Timepoint [2]
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Month 6, 12
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Secondary outcome [3]
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Percentage of Participants With Objective Response (OR)
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Assessment method [3]
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Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.
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Timepoint [3]
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Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
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Secondary outcome [4]
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Percentage of Participants With Disease Control at Week 6
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Assessment method [4]
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Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.
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Timepoint [4]
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Week 6
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Secondary outcome [5]
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Percentage of Participants With Disease Control at Week 12
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Assessment method [5]
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Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Duration of Response (DR)
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Assessment method [6]
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
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Timepoint [6]
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Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
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Secondary outcome [7]
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Time to Tumor Response (TTR)
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Assessment method [7]
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Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
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Timepoint [7]
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Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
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Secondary outcome [8]
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Plasma Concentration of Crizotinib
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Assessment method [8]
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Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
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Timepoint [8]
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Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5
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Secondary outcome [9]
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Number of Participants With Categorical Maximum QTcF for Crizotinib
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Assessment method [9]
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QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (\<) 450 milliseconds (msec), 450 msec to \<480 msec, 480 msec to \<500 msec, and more than or equal to (\>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
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Timepoint [9]
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Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2
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Secondary outcome [10]
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Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins
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Assessment method [10]
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Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.
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Timepoint [10]
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Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)
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Secondary outcome [11]
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Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
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Assessment method [11]
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TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer \[EORTC QLQ-LC13\]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.
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Timepoint [11]
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Baseline up to end of treatment (up to 112 weeks)
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Secondary outcome [12]
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European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
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Assessment method [12]
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EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.
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Timepoint [12]
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Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)
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Secondary outcome [13]
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European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)
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Assessment method [13]
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QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.
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Timepoint [13]
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Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
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Secondary outcome [14]
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European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)
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Assessment method [14]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
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Timepoint [14]
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Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
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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 a central laboratory)
* must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
* tumors must be 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
* current treatment in another clinical trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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Other design features
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Phase
Phase 3
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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
1/09/2009
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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
1/01/2016
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Sample size
Target
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Accrual to date
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Final
347
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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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Sydney Cancer Centre - 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
Country [1]
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United States of America
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State/province [1]
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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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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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New Hampshire
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New York
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Tennessee
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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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Bulgaria
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Plovdiv
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Sofia
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Varna
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Alberta
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Canada
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New Brunswick
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Canada
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Ontario
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China
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China
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Shanghai
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Caen Cedex 05
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France
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DIJON Cedex
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France
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Grenoble Cedex 09
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France
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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 14
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France
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Paris cedex 20
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France
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St Herblain Cedex
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France
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Villejuif
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Germany
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Dresden
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Germany
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Essen
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Germany
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Grosshansdorf
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Koeln
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Germany
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Muenchen
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Germany
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Oldenburg
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Germany
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Wiesbaden
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Greece
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Crete
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Greece
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Thessaloniki
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Greece
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Athens
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Hong Kong
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New Territories
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Hong Kong
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Pokfulam
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Hong Kong
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Shatin, 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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Ireland
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Dublin 8
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Ireland
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Galway
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Italy
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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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Torino
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Okayama
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Japan
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Osaka
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Japan
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Japan
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Tokyo
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Japan
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Fukuoka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Russian Federation
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Taipei
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Surrey
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Cheshire
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United Kingdom
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Eastleigh
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United Kingdom
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London
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Oxford
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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 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
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Trial website
https://clinicaltrials.gov/study/NCT00932893
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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. Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17. 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. Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Janne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum In: N Engl J Med. 2015 Oct 15;373(16):1582. doi: 10.1056/NEJMx150036. Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19. No abstract available.
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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/NCT00932893
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