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Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alectinib | Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR will be determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as assessed by physicians under routine clinical practice. Overall response rate was defined as the percentage of participants who had any evidence of Complete Response (CR) or Partial Response (PR): CR is defined as the disappearance of all target lesions and all nodes with short axis <10 millimeter (mm); PR is defined as >/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. Overall Response (OR) = CR + PR. |
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Inclusion Criteria:
- Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.
Exclusion Criteria:
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Participants with ALK-positive, locally advance or metastatic non-small cell lung cancer, who are administered alectinib at physician's discretion in Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea | |||
| Dong-A University Hospital |
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|
| Up to approximately 3 years |
| Complete Response (CR) | CR will be determined according to RECIST v1,1 as assessed by physicians under routine clinical practice and is defined as disappearance of all target lesions and all nodes with short axis <10 mm. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. | Up to approximately 3 years |
| Percentage of Participants with Partial Response (PR) | PR will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as >/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. | Up to approximately 3 years |
| Percentage of Participants with Stable Disease (SD) | SD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as neither response nor progression. Response is defined as at least >/=30% decrease in the sum of the longest diameter of target lesions. Progression is defined as >/= 20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and >/= 5 mm in absolute value. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. | Up to approximately 3 years |
| Percentage of Participants with Progressive Disease (PD) | PD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as >/=20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and >/= 5 mm in absolute value. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. | Up to approximately 3 years |
| Busan |
| 49201 |
| South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Dongnam Institute of Radiological & Medical Sciences | Busan | South Korea |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Konyang University Hospital | Daejeon | 35365 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Gangwon-do | 26426 | South Korea |
| Inje University Ilsan Paik Hospital | Gyeonggi-do | 10380 | South Korea |
| Uijeongbu St. Mary's Hospital | Gyeonggi-do | 11765 | South Korea |
| CHA Bundang Medical Center | Gyeonggi-do | 13496 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 14068 | South Korea |
| Bucheon St Mary's hospital | Gyeonggi-do | 14647 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Catholic Univ. of Incheon St.Mary's Hospital | Incheon | 21431 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Chonbuk National University Hospital | Jeollabuk-do | 54907 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Inje University, Sanggye-Paik Hospital | Seoul | 01757 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University | Seoul | 03722 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Gangdong Kyung Hee University Hospital | Seoul | 05278 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Soon Chun Hyang University Hospital; Department of Pulmonology and Allergy | Seoul | 140-743 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C582670 | alectinib |
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