A Rollover Protocol of Dacomitinib For Patients In Japan

Phase 2

Completed

• Conditions: NSCLC
• Interventions: Drug: Dacomitinib

• Registration Number: NCT02382796
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Study Start: 2015-07-10
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Results First Submitted: 2020-05-26
• Status Verified: 2020-06
• Results First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Results First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dacomitinib	Dacomitinib	3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.

Trial Locations

Locations (6)

Kanazawa University Hospital; 🇯🇵 Kanazawa City, Ishikawa, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan

Osaka City General Hospital Department of Clinical Oncology; 🇯🇵 Osaka-city, Osaka, Japan

Kindai University Hospital; 🇯🇵 Osakasayama, Osaka, Japan

Shizuoka Cancer Center; 🇯🇵 Suntougun, Shizuoka, Japan

Cancer Institute Hospital,Japanese Foundation for Cancer Research; 🇯🇵 Koto-Ku, Tokyo, Japan