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Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea

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ClinicalTrials.gov Identifier: NCT03271554
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Drug: Alectinib

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Study Type : Observational
Estimated Enrollment : 167 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : October 29, 2020
Estimated Study Completion Date : October 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Alectinib

Group/Cohort Intervention/treatment
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.
Drug: Alectinib
According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).
Other Name: Alecensa




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]
    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.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    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.

  2. Complete Response (CR) [ Time Frame: Up to approximately 3 years ]
    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.

  3. Percentage of Participants with Partial Response (PR) [ Time Frame: Up to approximately 3 years ]
    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.

  4. Percentage of Participants with Stable Disease (SD) [ Time Frame: Up to approximately 3 years ]
    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.

  5. Percentage of Participants with Progressive Disease (PD) [ Time Frame: Up to approximately 3 years ]
    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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with ALK-positive, locally advance or metastatic non-small cell lung cancer, who are administered alectinib at physician's discretion in Korea.
Criteria

Inclusion Criteria:

- Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.

Exclusion Criteria:

  • Hypersensitivity to alectinib or any ingredient of alectinib;
  • Pregnant or lactating women;
  • Pediatric subjects (age </=18 years);
  • Due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.

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): NCT03271554


Contacts
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Contact: Reference Study ID Number: ML30132 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Korea, Republic of
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of, 47392
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Kosin University Gospel Hospital Active, not recruiting
Busan, Korea, Republic of, 49267
Dongnam Institute of Radiological & Medical Sciences Recruiting
Busan, Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Korea, Republic of, 28644
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Korea, Republic of, 41404
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 41931
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of, 42472
Yonsei University Wonju Severance Christian Hospital Recruiting
Gangwon-do, Korea, Republic of, 26426
Dongguk University Ilsan Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 10326
Inje University Ilsan Paik Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 10380
Uijeongbu St. Mary's Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 11765
CHA Bundang Medical Center Recruiting
Gyeonggi-do, Korea, Republic of, 13496
Hallym University Sacred Heart Hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 14068
Hallym University Sacred Heart Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 14068
Bucheon St Mary's hospital Not yet recruiting
Gyeonggi-do, Korea, Republic of, 14647
St. Vincent's Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 16247
Pusan National University Yangsan Hospital Active, not recruiting
Gyeongsangnam-do, Korea, Republic of, 50612
Catholic Univ. of Incheon St.Mary's Hospital Recruiting
Incheon, Korea, Republic of, 21431
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Chonnam National University Hwasun Hospital Active, not recruiting
Jeollanam-do, Korea, Republic of, 58128
Inje University, Sanggye-Paik Hospital Recruiting
Seoul, Korea, Republic of, 01757
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Kangbuk Samsung Hospital Active, not recruiting
Seoul, Korea, Republic of, 03181
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 03722
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Gangdong Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 05278
VHS Medical Center Recruiting
Seoul, Korea, Republic of, 05368
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital Active, not recruiting
Seoul, Korea, Republic of, 06273
Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 07345
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 07985
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
Yonsei University Wonju Severance Christian Hospital Not yet recruiting
Wonju-Si, Korea, Republic of, 220-701
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03271554     History of Changes
Other Study ID Numbers: ML30132
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms