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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
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

Experimental: PF-0231066 -


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
Timepoint [1] 0 0
6 years
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events
Timepoint [2] 0 0
6 years
Secondary outcome [1] 0 0
Duration of Response (DR)
Timepoint [1] 0 0
6 years
Secondary outcome [2] 0 0
Time to Tumor Response (TTR)
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
6 years
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
6 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
6 years
Secondary outcome [6] 0 0
Probability of Survival
Timepoint [6] 0 0
6 years
Secondary outcome [7] 0 0
Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182
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)
Timepoint [8] 0 0
6 years
Secondary outcome [9] 0 0
Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)
Timepoint [9] 0 0
6 years
Secondary outcome [10] 0 0
QTc Prolongation in Participants
Timepoint [10] 0 0
6 years
Secondary outcome [11] 0 0
Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.
Timepoint [11] 0 0
6 years
Secondary outcome [12] 0 0
Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores
Timepoint [12] 0 0
6 years
Secondary outcome [13] 0 0
Mean Change From Baseline of QLQ-LC13 Scale Scores
Timepoint [13] 0 0
6 years
Secondary outcome [14] 0 0
Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)
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
Timepoint [15] 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
Sex
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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
1069
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
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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/ct2/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