Back to resultsA Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Crizotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Crizotinib, ALK, NSCLC, Non-Small Cell Lung Cancer, Asian
Eligibility Criteria
Inclusion Criteria:
- Proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
- Positive for translocation or inversion events involving the ALK gene locus
- Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy.
- Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
Exclusion Criteria:
- Current treatment on another therapeutic clinical trial.
- Prior therapy directly targeting ALK.
- Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
- Pregnancy or breastfeeding.
- Use of drugs or foods that are known potent CYP3A inducers/inhibitors/substrates with narrow therapeutic indices.
- Known HIV infection
- Known interstitial lung disease or interstitial fibrosis
- Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crizotinib
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate
Secondary Outcome Measures
Progression-Free Survival
Overall Survival
Disease Control Rate
Duration of Response
Time To Response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01500824
Brief Title
A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer
Official Title
Phase 2 Open-label Single Arm Study Of The Efficacy And Safety Of Crizotinib In East Asian Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Withdrawn
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based. Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary objectives are to evaluate clinical efficacy including median progression-free survival (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks, time to response (TTR), and duration of response (DR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Crizotinib, ALK, NSCLC, Non-Small Cell Lung Cancer, Asian
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crizotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Intervention Description
Crizotinib, 250 mg BID, will be administered orally at approximately the same time each day on a continuous daily dosing schedule
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
33 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
33 months
Title
Overall Survival
Time Frame
33 months
Title
Disease Control Rate
Time Frame
33 months
Title
Duration of Response
Time Frame
33 months
Title
Time To Response
Time Frame
33 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
Positive for translocation or inversion events involving the ALK gene locus
Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy.
Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
Exclusion Criteria:
Current treatment on another therapeutic clinical trial.
Prior therapy directly targeting ALK.
Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
Pregnancy or breastfeeding.
Use of drugs or foods that are known potent CYP3A inducers/inhibitors/substrates with narrow therapeutic indices.
Known HIV infection
Known interstitial lung disease or interstitial fibrosis
Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081027&StudyName=A%20Clinical%20Study%20Testing%20The%20Safety%20And%20Efficacy%20Of%20Crizotinib%20In%20East%20Asian%20Patients%20With%20Anaplastic%20Lymphoma%20Kinase%20%28ALK%29%20Positive
Description
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Learn more about this trial
A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer
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