Phase 2
Completed N=7
A Rollover Protocol of Dacomitinib For Patients In Japan
Source: ClinicalTrials.gov NCT02382796 ↗Enrolled (actual)
7
Serious AEs
28.6%
Results posted
Jul 2020
Primary outcomePrimary: 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 — 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
7 | — |
| SECONDARY Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
7; 2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02382796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.