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Trial record 1 of 1 for:    A8081005
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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932451
First received: June 30, 2009
Last updated: April 28, 2016
Last verified: April 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: PF-02341066

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1069 participants entered the study out of which 3 participants were withdrawn from the study before receiving study treatment because they were not eligible and were mistakenly entered into the interactive voice response system. Only 1066 participants received greater than or equal to 1 dose of crizotinib.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 144 participants in study NCT00932893 were also enrolled in this study to receive treatment with crizotinib, including 143 participants randomized to the chemotherapy arm then crossed over in this study and 1 participant initially erroneously randomized in the crizotinib arm but not treated.

Reporting Groups
  Description
Crizotinib 250 mg BID Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.

Participant Flow:   Overall Study
    Crizotinib 250 mg BID  
STARTED     1066  
COMPLETED     0  
NOT COMPLETED     1066  
Withdrawal by Subject                 64  
Lost to Follow-up                 3  
Death                 134  
Other reasons                 52  
Objective progression or relapse                 329  
Global deterioration of health                 286  
Adverse Event                 76  
Ongoing                 122  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
An Investigational Use Only (IUO) population (N=908) was all participants whose non-small cell lung cancer (NSCLC) was Fluorescent In-Situ Hybridization (FISH) ALK (Anaplastic Lymphoma Receptor Tyrosine Kinase) (+) by the central laboratory. A non‑IUO population (N=158) was all partcipants whose NSCLC was ALK (+) by local assay testing.

Reporting Groups
  Description
Crizotinib 250 mg BID Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.

Baseline Measures
    Crizotinib 250 mg BID  
Number of Participants  
[units: participants]
  1066  
Age  
[units: Years]
Mean (Standard Deviation)
  52.2  (12.3)  
Age, Customized  
[units: Participants]
 
< 65 years     894  
>=65 years     172  
Gender  
[units: Participants]
 
Female     601  
Male     465  
Race/Ethnicity, Customized  
[units: participants]
 
Chinese     252  
Japanese     81  
Korean     144  
White     532  
Black     20  
Other     19  
Other-Asian     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: 5 years ]

2.  Primary:   Percentage of Participants With Adverse Events   [ Time Frame: 5 years ]

3.  Secondary:   Duration of Response (DR)   [ Time Frame: 5 years ]

4.  Secondary:   Time to Tumor Response (TTR)   [ Time Frame: 5 years ]

5.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: 5 years ]

6.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 5 years ]

7.  Secondary:   Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.   [ Time Frame: 5 years ]

8.  Secondary:   Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale   [ Time Frame: 5 years ]

9.  Secondary:   Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)   [ Time Frame: 5 years ]

10.  Secondary:   Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182   [ Time Frame: 5 years ]

11.  Secondary:   Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)   [ Time Frame: 5 years ]

12.  Secondary:   Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)   [ Time Frame: 5 years ]

13.  Secondary:   QTc Prolongation in Participants   [ Time Frame: 5 years ]

14.  Secondary:   Overall Survival (OS)   [ Time Frame: 5 years ]

15.  Secondary:   Probability of Survival   [ Time Frame: 5 years ]

16.  Secondary:   Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores   [ Time Frame: 5 years ]

17.  Secondary:   Mean Change From Baseline of QLQ-LC13 Scale Scores   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Pharmacogenetic analysis of renal adverse events was not performed as no gene alleles have been identified in published literature with statistically significant association with renal toxicity to support a case control association analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00932451     History of Changes
Other Study ID Numbers: A8081005
2009-012504-13 ( EudraCT Number )
Study First Received: June 30, 2009
Results First Received: March 14, 2016
Last Updated: April 28, 2016
Health Authority: United States: Food and Drug Administration