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History of Changes for Study: NCT01154140
A Phase 3 Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014)
Latest version (submitted September 29, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 29, 2010 None (earliest Version on record)
2 July 27, 2010 Study Status
3 August 17, 2010 Study Status, References, Eligibility, Study Design and Study Identification
4 September 15, 2010 Study Status
5 October 12, 2010 Study Status
6 November 26, 2010 Study Status
7 December 21, 2010 Study Status and Contacts/Locations
8 January 17, 2011 Study Status and Contacts/Locations
9 March 2, 2011 Recruitment Status, Study Status and Contacts/Locations
10 March 10, 2011 Contacts/Locations, Study Status and Study Identification
11 April 8, 2011 Contacts/Locations and Study Status
12 April 22, 2011 Contacts/Locations and Study Status
13 April 28, 2011 Study Status
14 May 26, 2011 Contacts/Locations and Study Status
15 June 26, 2011 Contacts/Locations and Study Status
16 July 10, 2011 Contacts/Locations and Study Status
17 August 4, 2011 Contacts/Locations and Study Status
18 August 13, 2011 Contacts/Locations and Study Status
19 September 11, 2011 Contacts/Locations, Sponsor/Collaborators and Study Status
20 September 16, 2011 Contacts/Locations and Study Status
21 September 23, 2011 Contacts/Locations and Study Status
22 October 11, 2011 Contacts/Locations and Study Status
23 October 18, 2011 Contacts/Locations and Study Status
24 October 24, 2011 Contacts/Locations and Study Status
25 October 31, 2011 Contacts/Locations and Study Status
26 November 27, 2011 Contacts/Locations and Study Status
27 December 31, 2011 Contacts/Locations and Study Status
28 February 5, 2012 Contacts/Locations and Study Status
29 March 9, 2012 Contacts/Locations and Study Status
30 April 5, 2012 Contacts/Locations and Study Status
31 April 24, 2012 Contacts/Locations and Study Status
32 May 22, 2012 Contacts/Locations and Study Status
33 June 4, 2012 Contacts/Locations and Study Status
34 June 21, 2012 Contacts/Locations, Eligibility, Outcome Measures and Study Status
35 June 29, 2012 Contacts/Locations and Study Status
36 July 5, 2012 Contacts/Locations and Study Status
37 July 16, 2012 Contacts/Locations and Study Status
38 August 13, 2012 Contacts/Locations and Study Status
39 September 10, 2012 Contacts/Locations and Study Status
40 September 27, 2012 Contacts/Locations and Study Status
41 October 11, 2012 Contacts/Locations, Outcome Measures and Study Status
42 November 9, 2012 Contacts/Locations and Study Status
43 December 5, 2012 Contacts/Locations and Study Status
44 January 3, 2013 Study Status
45 February 6, 2013 Study Status and Contacts/Locations
46 March 6, 2013 Contacts/Locations and Study Status
47 April 4, 2013 Contacts/Locations and Study Status
48 May 3, 2013 Contacts/Locations and Study Status
49 May 31, 2013 Contacts/Locations and Study Status
50 June 3, 2013 Contacts/Locations and Study Status
51 July 1, 2013 Contacts/Locations and Study Status
52 August 5, 2013 Outcome Measures, Study Status and Contacts/Locations
53 September 3, 2013 Study Status and Contacts/Locations
54 September 23, 2013 Recruitment Status, Study Status and Contacts/Locations
55 October 10, 2013 Study Status
56 November 1, 2013 Study Status and Contacts/Locations
57 December 16, 2013 Study Status and Contacts/Locations
58 January 14, 2014 Study Status
59 February 15, 2014 Study Status
60 March 14, 2014 Study Status and Contacts/Locations
61 March 17, 2014 Study Status
62 April 2, 2014 Study Status, Contacts/Locations and Outcome Measures
63 May 1, 2014 Study Status
64 May 19, 2014 Contacts/Locations and Study Status
65 June 19, 2014 Study Status
66 July 8, 2014 Study Status
67 August 1, 2014 Recruitment Status, Study Status and Contacts/Locations
68 September 8, 2014 Recruitment Status, Study Status and Contacts/Locations
69 October 30, 2014 Contacts/Locations, Study Status and Study Identification
70 November 6, 2014 Study Status
71 December 19, 2014 Outcome Measures, Study Status, Study Design, Results and Contacts/Locations
72 February 3, 2015 Contacts/Locations, Study Status and Study Identification
73 March 20, 2015 Study Status
74 June 15, 2015 Contacts/Locations and Study Status
75 September 27, 2015 Contacts/Locations and Study Status
76 November 30, 2015 Outcome Measures, Contacts/Locations, Study Status and Study Identification
77 February 25, 2016 Contacts/Locations and Study Status
78 May 19, 2016 Contacts/Locations and Study Status
79 September 30, 2016 Contacts/Locations, Study Status and Study Identification
80 January 17, 2017 Recruitment Status, Contacts/Locations, Study Status and Baseline Characteristics
81 April 13, 2017 Study Status, Contacts/Locations, Outcome Measures and Baseline Characteristics
82 September 29, 2017 Outcome Measures, Adverse Events, Participant Flow, Contacts/Locations, Baseline Characteristics and Study Status
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Study NCT01154140
Submitted Date:  June 29, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: A8081014
Brief Title: A Phase 3 Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014)
Official Title: Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2010
Overall Status: Not yet recruiting
Study Start: December 2010
Primary Completion: November 2013 [Anticipated]
Study Completion: November 2013 [Anticipated]
First Submitted: June 29, 2010
First Submitted that
Met QC Criteria:
June 29, 2010
First Posted: June 30, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 29, 2010
Last Update Posted: June 30, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
Detailed Description:
Open or close this module Conditions
Conditions: Non Squamous Lung Cancer
Keywords: open label
randomized Phase 3
first line treatment
non squamous lung cancer
ALK translocation event positive
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 344 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: A Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
Active Comparator: B Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression Free Survival [PFS] based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)
[ Time Frame: 35 months ]

Secondary Outcome Measures:
1. Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR]
[ Time Frame: 35 months ]

2. Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities
[ Time Frame: 35 months ]

3. Plasma concentrations of crizotinib (including its active moieties, if appropriate)
[ Time Frame: 35 months ]

4. Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion
[ Time Frame: 35 months ]

5. Patient reported outcome measures of pain, dyspnea, or cough, disease/treatment-related symptoms, and general health status and Health Care Resource Utilization [HCRU]
[ Time Frame: 35 months ]

6. Overall Survival [OS] at 6 months 12 months and overall
[ Time Frame: 35 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  • Positive for translocation or inversion events involving the ALK gene locus
  • No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  • Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.

Exclusion Criteria:

  • Current treatment on another therapeutic clinical trial.
  • Prior therapy directly targeting ALK.
  • Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, uncontrolled congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  • 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 CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  • Known HIV infection
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Central Contact Backup: Pfizer Oncology Clinical Trial Information Service
Telephone: 1-877-369-9753
Email: PfizerCancerTrials@emergingmed.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD:

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