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Trial record 1 of 1 for:    NCT01858389
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A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01858389
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 21, 2013
Results First Submitted Date  ICMJE September 13, 2016
Results First Posted Date  ICMJE July 18, 2017
Last Update Posted Date July 18, 2017
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • Best Overall Response (BOR) in Participants With T790M Mutation [ Time Frame: From baseline until disease progression, up to 61 weeks. ]
    BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective.
  • Objective Response Rate (ORR) in Participants With T790M Mutation [ Time Frame: From baseline to disease progression, up to 61 weeks. ]
    ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • Best Overall Response [ Time Frame: Baseline up to 78 weeks ]
  • Objective Response Rate [ Time Frame: Baseline up to 78 weeks ]
Change History Complete list of historical versions of study NCT01858389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • Disease Control Rate (DCR) for Participants With T790M Mutation [ Time Frame: From baseline to baseline to disease progression, up to 61 weeks. ]
    DCR was calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST, v1.1, relative to the total number of participants enrolled in the cohort. If baseline tumor assessment was inadequate for a participant, and the participant could not be assessed for RECIST responses and had no objective status of stable disease documented at least 6 weeks after the start date and before the progression, the participant was only counted in the denominator. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. DCR was analyzed only for participants with T790M mutation according to the study objective.
  • Duration of Response in Participants With T790M Mutation [ Time Frame: From baseline to date of disease progression or death, up to 61 weeks. ]
    Duration of response was defined as the time from first documentation of response (CR or PR, whichever occurred first) to the date of disease progression or to death due to any cause, whichever occurred first. CR and PR were defined using RECIST, v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. DR was only calculated and summarized for the subgroup of participants with an objective tumor response in the cohort of participants with T790M mutation.
  • Progression-free Survival [ Time Frame: From baseline to disease progression or death, up to 61 weeks. ]
    Progression-free survival was defined as the time from the date of first dosing of dacomitinib to the date of disease progression by RECIST v1.1, per the investigators' assessment, or death due to any cause, whichever occurred first. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
  • Progression-free Survival at 4 Months [ Time Frame: Month 4 ]
    Progression-free survival at 4 months was defined as the percentage of participants who were alive without disease progression at 4 months relative to all participants enrolled. Disease progression was defined by RECIST v1.1. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
  • Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265 [ Time Frame: Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. ]
    Cmax was observed directly from data. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.
  • Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265 [ Time Frame: Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. ]
    Tmax was observed directly from data as time of first occurrence. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.
  • Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG) [ Time Frame: From Baseline to Cycle 0, Day 4 ]
    ECGs recorded on Day 1 of Cycle 0 were used as baseline. For the ECGs assessments, the following directions were followed by the ECG central laboratory: Blinding of ECG readers to treatment, time, and day identifiers. Review of ECGs from a particular participant was performed by a single reader. Prespecification of the lead for internal measurements. Baseline and on-treatment ECG assessments were based on the same lead.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • Disease Control Rate [ Time Frame: Start of study drug until RECIST defined progressive disease, or discontinuation from treatment, or start of another anti-cancer treatment assessed up to 78 weeks ]
  • Duration of Response [ Time Frame: From start of treatment to disease progression or death due to any cause or discontinuation from the treatment or start of a new anti-cancer treatment assessed up to 78 weeks ]
  • Progression-free Survival [ Time Frame: From start of treatment to disease progression or death due to any cause or discontinuation from the treatment or start of a new anti-cancer treatment assessed up to 78 weeks ]
  • Progression-free Survival at 4 Months [ Time Frame: From start of treatment to disease progression or death due to any cause or discontinuation from the treatment or start of a new anti-cancer treatment assessed up to 78 weeks ]
  • delta QT corrected [ Time Frame: Cycle 0 days 1 through 4: pre-dose (0 hour) up to 10 hours post dose ]
  • delta QT corrected and dacomitinib plasma concentration [ Time Frame: Cycle 0 days 1 through 4: pre-dose (0 hour) up to 10 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc
Brief Summary This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Dacomitinib
    Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.
  • Drug: Dacomitinib
    Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.
Study Arms  ICMJE
  • Experimental: Cohort A
    Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor.
    Intervention: Drug: Dacomitinib
  • Experimental: Cohort B
    Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.
    Intervention: Drug: Dacomitinib
Publications * Yu HA, Ahn MJ, Cho BC, Gerber DE, Natale RB, Socinski MA, Giri N, Quinn S, Sbar E, Zhang H, Giaccone G. Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers. Lung Cancer. 2017 Oct;112:195-199. doi: 10.1016/j.lungcan.2017.08.017. Epub 2017 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2017)
41
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2013)
35
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
  • Evidence of T790M mutation to enroll in Cohort A.
  • Evidence of measurable disease by radiographic technique.
  • Adequate organ function.

Exclusion Criteria:

  • Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
  • Symptomatic brain metastases.
  • Uncontrolled or significant cardiovascular disease.
  • Pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01858389
Other Study ID Numbers  ICMJE A7471047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2017

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