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Long-term Observation PMS for Afatinib

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ClinicalTrials.gov Identifier: NCT02131259
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Drug: Afatinib dimaleate

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Study Type : Observational
Actual Enrollment : 1605 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.
Actual Study Start Date : May 7, 2014
Actual Primary Completion Date : December 28, 2016
Actual Study Completion Date : December 28, 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Afatinib Drug: Afatinib dimaleate
20mg - 50mg

Primary Outcome Measures :
  1. Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks. ]

    This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied".

    The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.

Secondary Outcome Measures :
  1. Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1] [ Time Frame: 52 weeks. ]

    Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor [TKI]-naïve patients and the TKI pre-treated patients.

    Overall response was calculated with 95% Clopper-Pearson confidence interval.

    OR = (CR+PR)/(CR+PR+SD+PD+Unknown)*100.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion criteria:

- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.

Exclusion criteria:

- None

Information from the National Library of Medicine

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): NCT02131259

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02131259    
Other Study ID Numbers: 1200.181
First Posted: May 6, 2014    Key Record Dates
Results First Posted: September 7, 2018
Last Update Posted: September 7, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action