A Rollover Protocol of Dacomitinib For Patients In Japan

Pfizer

Status and phase: Completed; Phase 2

Conditions: NSCLC

Treatments: Drug: Dacomitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02382796

A7471055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 1 patient group

Dacomitinib

Experimental group

Description:

3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing

Treatment:

Drug: Dacomitinib