Long-term Observation PMS for Afatinib

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Afatinib dimaleate

• Registration Number: NCT02131259
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-06
• Study Start: 2014-05-07
• Primary Completion: 2016-12-28
• Study Completion: 2016-12-28
• Results First Submitted: 2017-12-08
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Results First Posted: 2018-09-07
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1605

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Afatinib	Afatinib dimaleate	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Drug Reactions (ADRs)	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

Name	Time	Method
Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]	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.

Trial Locations

Locations (432)

Boehringer Ingelheim Investigational Site 145; 🇯🇵 Adachi Tokyo, Japan

Boehringer Ingelheim Investigational Site 429; 🇯🇵 Aira Kagoshima, Japan

Boehringer Ingelheim Investigational Site 64; 🇯🇵 Aizuwakamatsu Fukushima, Japan

Boehringer Ingelheim Investigational Site 44; 🇯🇵 Akita Akita, Japan

Boehringer Ingelheim Investigational Site 45; 🇯🇵 Akita Akita, Japan

Boehringer Ingelheim Investigational Site 46; 🇯🇵 Akita Akita, Japan

Boehringer Ingelheim Investigational Site 47; 🇯🇵 Akita Akita, Japan

Boehringer Ingelheim Investigational Site 333; 🇯🇵 Amagasaki Hyogo, Japan

Boehringer Ingelheim Investigational Site 266; 🇯🇵 Anjo Aichi, Japan

Boehringer Ingelheim Investigational Site 27; 🇯🇵 Aomori Aomori, Japan

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Boehringer Ingelheim Investigational Site 145

🇯🇵Adachi Tokyo, Japan