Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03410108
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2018-01-11
Brief Title:
Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase ALK-Positive Non-Small Cell Lung Cancer NSCLC
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Single-Arm Multicenter Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate efficacy and safety of brigatinib in Japanese participants with anaplastic lymphoma kinase ALK-positive NSCLC
Detailed Description:
The drug being tested in this study is called brigatinib Brigatinib is being tested in participants with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese participants with ALK-positive NSCLC
The study will enroll approximately 110 participants Participants will be enrolled in non-randomized and opened manner
- Brigatinib 90 mg for the first 7 days followed by Brigatinib 180 mg of Brigatinib tablets once daily in a 28-days cycle
All participants will be asked to take tablets of brigatinib once daily with or without food throughout the study
This multi-center trial will be conducted in Japan The overall time to participate in this study is approximately 53 months Participants will make multiple visits to the clinic during the treatment period and posttreatment period including a follow-up assessment after last dose of study drug
The study will enroll approximately 110 participants Participants will be enrolled in non-randomized and opened manner
- Brigatinib 90 mg for the first 7 days followed by Brigatinib 180 mg of Brigatinib tablets once daily in a 28-days cycle
All participants will be asked to take tablets of brigatinib once daily with or without food throughout the study
This multi-center trial will be conducted in Japan The overall time to participate in this study is approximately 53 months Participants will make multiple visits to the clinic during the treatment period and posttreatment period including a follow-up assessment after last dose of study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JapicCTI-183823 | REGISTRY | JapicCTI | None |
| U1111-1204-8752 | OTHER | None | None |