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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
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
Secondary ID [1] 0 0
2009-012595-27
Secondary ID [2] 0 0
A8081007
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
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
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)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization until death (up to 4.5 years)
Secondary outcome [2] 0 0
Overall Survival Probability at Months 6 and 12
Timepoint [2] 0 0
Month 6, 12
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [3] 0 0
Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Secondary outcome [4] 0 0
Percentage of Participants With Disease Control at Week 6
Timepoint [4] 0 0
Week 6
Secondary outcome [5] 0 0
Percentage of Participants With Disease Control at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Duration of Response (DR)
Timepoint [6] 0 0
Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Secondary outcome [7] 0 0
Time to Tumor Response (TTR)
Timepoint [7] 0 0
Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Secondary outcome [8] 0 0
Plasma Concentration of Crizotinib
Timepoint [8] 0 0
Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5
Secondary outcome [9] 0 0
Number of Participants With Categorical Maximum QTcF for Crizotinib
Timepoint [9] 0 0
Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2
Secondary outcome [10] 0 0
Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
Timepoint [11] 0 0
Baseline up to end of treatment (up to 112 weeks)
Secondary outcome [12] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Timepoint [12] 0 0
Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)
Secondary outcome [13] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)
Timepoint [13] 0 0
Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
Secondary outcome [14] 0 0
European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)
Timepoint [14] 0 0
Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior treatment with PF-02341066
* current treatment in another clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
347
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Cancer Centre - 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
Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Hawaii
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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
Country [16] 0 0
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North Carolina
Country [17] 0 0
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Ohio
Country [18] 0 0
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Oregon
Country [19] 0 0
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Washington
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BA
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RJ
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RS
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Brazil
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SP
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Plovdiv
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Sofia
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Varna
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Marseille Cedex 20
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Essen
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Heidelberg
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Koeln
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Muenchen
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Oldenburg
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Greece
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Crete
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Thessaloniki
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Athens
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Shatin, New Territories
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Budapest
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Debrecen
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Dublin 8
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Roma
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Aichi
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Gyeonggi-do
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Seoul
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Netherlands
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NAP
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Russian Federation
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Moscow
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Sochi
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St. Petersburg
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Asturias
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Barcelona
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Sevilla
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Sweden
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Stockholm
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Taiwan
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Tainan
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Taipei
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United Kingdom
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Surrey
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Cheshire
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Eastleigh
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London
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Manchester
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Oxford
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United Kingdom
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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
Trial website
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

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