A Rollover Protocol of Dacomitinib For Patients In Japan

• ClinicalTrials.gov Identifier: NCT02382796
• Recruitment Status: Completed
• First Posted: March 9, 2015
• Results First Posted: July 2, 2020
• Last Update Posted: July 2, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
NSCLC	Drug: Dacomitinib	Phase 2

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dacomitinib; 3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] January 28, 2015

Statistical Analysis Plan  [PDF] July 2, 2019

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02382796
• Other Study ID Numbers: A7471055
• First Posted: March 9, 2015
• 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