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A Rollover Protocol of Dacomitinib For Patients In Japan

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ClinicalTrials.gov Identifier: NCT02382796
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Dacomitinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TREATMENT ACCESS PROTOCOL FOR PATIENTS PREVIOUSLY TREATED WITH DACOMITINIB ON A CLINICAL TRIAL IN JAPAN
Actual Study Start Date : July 10, 2015
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dacomitinib

Arm Intervention/treatment
Experimental: Dacomitinib
3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382796


Locations
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Japan
Kanazawa University Hospital
Kanazawa City, Ishikawa, Japan, 9208641
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Osaka City General Hospital Department of Clinical Oncology
Osaka-city, Osaka, Japan, 534-0021
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Suntougun, Shizuoka, Japan, 411-8777
Cancer Institute Hospital,Japanese Foundation for Cancer Research
Koto-Ku, Tokyo, Japan, 135-8550
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] January 28, 2015
Statistical Analysis Plan  [PDF] July 2, 2019

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02382796    
Other Study ID Numbers: A7471055
First Posted: March 9, 2015    Key Record Dates
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests