- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02285361
GIOTRIF rPMS in Korean Patients With NSCLC
A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Multiple Locations, 대한민국
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion criteria:
- Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
- Age = 19 years at enrolment
- Patients who have signed on the data release consent form
Exclusion criteria:
- Known hypersensitivity to afatinib or any of its excipients
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients for whom GIOTRIF® is contraindicated according to the local label
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
GIOTRIF
|
NSCLC with GIOTRIF 20mg
NSCLC with GIOTRIF 40mg
NSCLC with GIOTRIF 30mg
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Adverse Drug Reactions (ADRs)
기간: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
Percentage of participants with Adverse Drug Reactions (ADRs).
|
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression-Free Survival (PFS) Rate at 48 Weeks
기간: From week 0 until week 48. Up to 48 weeks.
|
Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC). If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression. PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve. |
From week 0 until week 48. Up to 48 weeks.
|
Percentage of Participants With Best Response
기간: Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
|
Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site. Tumour response according to investigator's assessment Each patient will be assigned to one of the following categories:
|
Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
|
Overall Survival (OS)
기간: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS. For patients with known date of death: OS [days] = date of death - (date of start of treatment) + 1 For patients known not death case: OS (censored) [days] = date of last contact showing no death - (date of start of treatment) + 1. |
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
암종, 비소세포폐에 대한 임상 시험
-
Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
GIOTRIF 20mg에 대한 임상 시험
-
South China Center For Innovative PharmaceuticalsXiangya Hospital of Central South University완전한
-
Yale UniversityBoehringer Ingelheim; National Comprehensive Cancer Network모병
-
Medicines for Malaria VentureQ-Pharm Pty Limited종료됨