Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03535740
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2018-05-09
Brief Title:
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive ALK Advanced Non-Small-Cell Lung Cancer NSCLC Progressed on Alectinib or Ceritinib
Sponsor:
Ariad Pharmaceuticals
Organization:
Takeda
Study Overview
Official Title:
Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive ALK Advanced Non-Small-Cell Lung Cancer NSCLC Progressed on Alectinib or Ceritinib
Status:
COMPLETED
Status Verified Date:
2024-09
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:
ALTA-2
Brief Summary:
The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate ORR by response evaluation criteria in solid tumors Response Evaluation Criteria in Solid Tumors RECIST in participants with ALK locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib
Detailed Description:
The drug being tested in this study is called brigatinib AP26113 Brigatinib is being tested to treat people who have anaplastic lymphoma kinase-positive ALK advanced non-small-cell lung cancer NSCLC
The study will enroll approximately 103 patients Participants will be assigned to the treatment group
Brigatinib
All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7 days followed by brigatinib 180 mg at the same time each day throughout the study Participants with progressive disease had an option to receive an escalated dose of brigatinib 240 mg as per investigators discretion in case no toxicities greater than grade 2 are experienced
This multicenter trial will be conducted worldwide The overall time to participate in this study is approximately 3 years Participants will make multiple visits to the clinic and 30 days after last dose of study drug for a follow-up assessment
The study will enroll approximately 103 patients Participants will be assigned to the treatment group
Brigatinib
All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7 days followed by brigatinib 180 mg at the same time each day throughout the study Participants with progressive disease had an option to receive an escalated dose of brigatinib 240 mg as per investigators discretion in case no toxicities greater than grade 2 are experienced
This multicenter trial will be conducted worldwide The overall time to participate in this study is approximately 3 years Participants will make multiple visits to the clinic and 30 days after last dose of study drug for a follow-up assessment
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 |
|---|---|---|---|
| 2018-000635-27 | EUDRACT_NUMBER | None | None |
| NL6646207818 | REGISTRY | None | None |
| JapicCTI-194915 | REGISTRY | JapicCTI | None |