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Completed

NCT Number: NCT02382796

A Rollover Protocol of Dacomitinib For Patients In Japan

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.

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Key information

Conditions

NSCLC

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kanazawa University Hospital, Kanazawa, Ishikawa-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dacomitinib

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

TREATMENT ACCESS PROTOCOL FOR PATIENTS PREVIOUSLY TREATED WITH DACOMITINIB ON A CLINICAL TRIAL IN JAPAN

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2015
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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