A Rollover Protocol of Dacomitinib For Patients In Japan
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ClinicalTrials.gov Identifier: NCT02382796 |
Recruitment Status :
Completed
First Posted : March 9, 2015
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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NSCLC | Drug: Dacomitinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | TREATMENT ACCESS PROTOCOL FOR PATIENTS PREVIOUSLY TREATED WITH DACOMITINIB ON A CLINICAL TRIAL IN JAPAN |
Actual Study Start Date : | July 10, 2015 |
Actual Primary Completion Date : | May 30, 2019 |
Actual Study Completion Date : | May 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Dacomitinib
3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing
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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. |
- 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 [ Time Frame: 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.
- Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382796
Japan | |
Kanazawa University Hospital | |
Kanazawa City, Ishikawa, Japan, 9208641 | |
Kurashiki Central Hospital | |
Kurashiki, Okayama, Japan, 710-8602 | |
Osaka City General Hospital Department of Clinical Oncology | |
Osaka-city, Osaka, Japan, 534-0021 | |
Kindai University Hospital | |
Osakasayama, Osaka, Japan, 589-8511 | |
Shizuoka Cancer Center | |
Suntougun, Shizuoka, Japan, 411-8777 | |
Cancer Institute Hospital,Japanese Foundation for Cancer Research | |
Koto-Ku, Tokyo, Japan, 135-8550 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Documents provided by Pfizer:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02382796 |
Other Study ID Numbers: |
A7471055 |
First Posted: | March 9, 2015 Key Record Dates |
Results First Posted: | July 2, 2020 |
Last Update Posted: | July 2, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |