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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition NSCLC
Intervention Drug: Dacomitinib
Enrollment 7
Recruitment Details  
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.
Arm/Group Title Dacomitinib
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 7
Completed 0
Not Completed 7
Reason Not Completed
Global deterioration of health status             1
Objective progression or relapse             3
Commercial dacomitinib became available             3
Arm/Group Title Dacomitinib
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who received any study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
71.4  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian (Japanese) Number Analyzed 7 participants
7
7
 100.0%
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study medication.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
7
 100.0%
2.Secondary Outcome
Title Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any study medication.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
AEs 7
7
 100.0%
SAEs 7
2
  28.6%
Time Frame Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Dacomitinib
Hide Arm/Group Description 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.
All-Cause Mortality
Dacomitinib
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Serious Adverse Events
Dacomitinib
Affected / at Risk (%)
Total   2/7 (28.57%) 
Gastrointestinal disorders   
Ileus * 1  1/7 (14.29%) 
Infections and infestations   
Lung infection * 1  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Intraductal papillary mucinous neoplasm * 1  1/7 (14.29%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dacomitinib
Affected / at Risk (%)
Total   7/7 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/7 (14.29%) 
Cardiac disorders   
Palpitations * 1  1/7 (14.29%) 
Eye disorders   
Blepharitis * 1  1/7 (14.29%) 
Cataract * 1  1/7 (14.29%) 
Corneal erosion * 1  1/7 (14.29%) 
Dry eye * 1  1/7 (14.29%) 
Posterior capsule opacification * 1  1/7 (14.29%) 
Swelling of eyelid * 1  1/7 (14.29%) 
Gastrointestinal disorders   
Diarrhoea * 1  2/7 (28.57%) 
Stomatitis * 1  1/7 (14.29%) 
General disorders   
Face oedema * 1  1/7 (14.29%) 
Fatigue * 1  1/7 (14.29%) 
Malaise * 1  1/7 (14.29%) 
Oedema peripheral * 1  1/7 (14.29%) 
Pain * 1  1/7 (14.29%) 
Peripheral swelling * 1  1/7 (14.29%) 
Infections and infestations   
Bronchitis * 1  1/7 (14.29%) 
Cellulitis * 1  1/7 (14.29%) 
Conjunctivitis * 1  1/7 (14.29%) 
Lung infection * 1  2/7 (28.57%) 
Nasopharyngitis * 1  1/7 (14.29%) 
Paronychia * 1  2/7 (28.57%) 
Pleural infection * 1  1/7 (14.29%) 
Staphylococcal infection * 1  1/7 (14.29%) 
Upper respiratory tract infection * 1  1/7 (14.29%) 
Injury, poisoning and procedural complications   
Contusion * 1  2/7 (28.57%) 
Fall * 1  1/7 (14.29%) 
Rib fracture * 1  1/7 (14.29%) 
Investigations   
Aspartate aminotransferase increased * 1  1/7 (14.29%) 
Blood creatine phosphokinase increased * 1  1/7 (14.29%) 
White blood cell count decreased * 1  1/7 (14.29%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/7 (14.29%) 
Hyperamylasaemia * 1  1/7 (14.29%) 
Hyperlipidaemia * 1  1/7 (14.29%) 
Hyponatraemia * 1  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/7 (14.29%) 
Flank pain * 1  1/7 (14.29%) 
Musculoskeletal pain * 1  1/7 (14.29%) 
Spinal stenosis * 1  1/7 (14.29%) 
Spondylolisthesis * 1  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Intraductal papillary mucinous neoplasm * 1  1/7 (14.29%) 
Nervous system disorders   
Headache * 1  2/7 (28.57%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/7 (14.29%) 
Epistaxis * 1  1/7 (14.29%) 
Hypoxia * 1  1/7 (14.29%) 
Oropharyngeal pain * 1  1/7 (14.29%) 
Pleural effusion * 1  1/7 (14.29%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  1/7 (14.29%) 
Dermatitis acneiform * 1  1/7 (14.29%) 
Dermatitis contact * 1  1/7 (14.29%) 
Dry skin * 1  2/7 (28.57%) 
Pruritus * 1  1/7 (14.29%) 
Purpura * 1  1/7 (14.29%) 
Rash maculo-papular * 1  1/7 (14.29%) 
Urticaria * 1  2/7 (28.57%) 
Vascular disorders   
Hypertension * 1  1/7 (14.29%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02382796    
Other Study ID Numbers: A7471055
First Submitted: March 3, 2015
First Posted: March 9, 2015
Results First Submitted: May 26, 2020
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020