NSCLC
Conditions
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.
Interventions
DRUGDacomitinib
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.
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Pre-assignment details
It is a multi-center,treatment extension study open in Japan only.Eligible participants were those with advanced non-small cell lung cancer who received and tolerated dacomitinib in studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]) in Japan and had the potential to derive continued clinical benefit based on investigator judgment.
Participants by arm
| Arm | Count |
|---|---|
| Dacomitinib Participants received continuous daily dosing of dacomitinib at a dose of 45 mg, 30 mg, or 15 mg. The starting dose of dacomitinib on this treatment extension study was the participant's ending dose from the prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]). Dacomitinib was provided as tablets for oral administration. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Commercial dacomitinib became available | 3 |
| Overall Study | Global deterioration of health status | 1 |
| Overall Study | Objective progression or relapse | 3 |
Baseline characteristics
| Characteristic | Dacomitinib |
|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Asian (Japanese) 7 | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 2 / 7 |
Outcome results
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.
Time frame: 4 years
Population: All participants who received any study medication.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dacomitinib | 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 | 7 Participants |
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.
Time frame: Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
Population: All participants who received any study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dacomitinib | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 7 | 7 Participants |
| Dacomitinib | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 7 | 2 Participants |