A Rollover Protocol of Dacomitinib For Patients In Japan

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382796
• Other study ID #: A7471055
• Status: Completed
• Phase: Phase 2
• Start date: July 10, 2015
• Est. completion date: May 30, 2019

Study information

• Verified date: June 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

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.

Locations

Country	Name	City	State
Japan	Kanazawa University Hospital	Kanazawa City	Ishikawa
Japan	Cancer Institute Hospital,Japanese Foundation for Cancer Research	Koto-Ku	Tokyo
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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 years
Secondary	Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.	Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks

External Links

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