Working… Menu

A Rollover Protocol of Dacomitinib For Patients In Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02382796
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE March 3, 2015
First Posted Date  ICMJE March 9, 2015
Results First Submitted Date  ICMJE May 26, 2020
Results First Posted Date  ICMJE July 2, 2020
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE July 10, 2015
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study [ Time Frame: 4 years ]
To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Incidence of AEs and SAEs [ Time Frame: Baseline up to last dose of study medication up to 2 years ]
listings/ type, frequency, severity, timing and relationship of study therapy of AE/SAE
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks ]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Rollover Protocol of Dacomitinib For Patients In Japan
Brief Summary The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.
Detailed Description The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE Drug: Dacomitinib
Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.
Study Arms  ICMJE Experimental: Dacomitinib
3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing
Intervention: Drug: Dacomitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
Actual Study Completion Date  ICMJE May 30, 2019
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who received dacomitinib on another clinical trial in Japan
  • Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

  • Patients who meet one or more study withdrawal criteria on the prior study
  • Participation in other studies involving other investigational drug(s) during study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02382796
Other Study ID Numbers  ICMJE A7471055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date June 2020

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