A 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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154140
First received: June 29, 2010
Last updated: July 8, 2014
Last verified: July 2014

June 29, 2010
July 8, 2014
January 2011
November 2013   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
The period from study entry until disease progression, death or date of last contact. Progression Free Survival [PFS] based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01154140 on ClinicalTrials.gov Archive Site
  • Number of Participants With Objective Response. [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    Number of participants with Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR], Time to Response [TTR], intra-cranial and extra-cranial Disease Control Rate [DCR]
  • Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of crizotinib (including its active moieties, if appropriate) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall Survival [OS] at 12 months, 18 months and overall [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR] [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of crizotinib (including its active moieties, if appropriate) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall Survival [OS] at 6 months 12 months and overall [ Time Frame: 35 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 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
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

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Squamous Lung Cancer
  • Drug: treatment
    crizotinib 250mg orally continuous twice daily dosing
  • 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
  • Experimental: A
    Intervention: Drug: treatment
  • Active Comparator: B
    Intervention: Drug: treatment
Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
334
February 2015
November 2013   (final data collection date for primary outcome measure)

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.
  • 18 years of age or older with the exception of India which has an upper age limit of 65 years old

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. - - 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Finland,   France,   Germany,   Hong Kong,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Luxembourg,   Mexico,   Netherlands,   Norway,   Peru,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom
 
NCT01154140
A8081014
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP