Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02094573
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2014-03-18
Brief Title:
A Study to Evaluate the Efficacy of Brigatinib AP26113 in Participants With Anaplastic Lymphoma Kinase ALK-Positive Non-small Cell Lung Cancer NSCLC Previously Treated With Crizotinib
Sponsor:
Ariad Pharmaceuticals
Organization:
Takeda
Study Overview
Official Title:
A Randomized Phase 2 Study of AP26113 in Patients With ALK-positive Non-small Cell Lung Cancer NSCLC Previously Treated With Crizotinib
Status:
COMPLETED
Status Verified Date:
2021-02
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 the efficacy and safety of two different dosing regimens of brigatinib AP26113 in participants with ALK-positive locally advanced or metastatic non-small cell lung cancer NSCLC whose disease has progressed on therapy with crizotinib
Detailed Description:
The drug being tested in this study is called brigatinib AP26113 Brigatinib was tested to treat people with anaplastic lymphoma kinase ALK-positive metastatic non-small cell lung cancer NSCLC who have progressed on or were intolerant to crizotinib This study looked at the efficacy of brigatinib
The study enrolled 222 patients Participants were randomly assigned by chance like flipping a coin to one of the two treatment groups
Brigatinib 90 mg
Brigatinib 90 mg -180 mg
All participants were asked to take a tablet orally once daily until disease progression or intolerable toxicity Participants in Brigatinib 90 mg - 180 mg received 180 mg with a 7-day lead-in at 90 mg
This multi-center trial was conducted worldwide The overall time to participate in this study is up to 3 years Participants will make multiple visits to the clinic and 3 months after the End-of-Treatment visit Follow-up is intended to continue for 2 years after the last participants was enrolled into the study
The study enrolled 222 patients Participants were randomly assigned by chance like flipping a coin to one of the two treatment groups
Brigatinib 90 mg
Brigatinib 90 mg -180 mg
All participants were asked to take a tablet orally once daily until disease progression or intolerable toxicity Participants in Brigatinib 90 mg - 180 mg received 180 mg with a 7-day lead-in at 90 mg
This multi-center trial was conducted worldwide The overall time to participate in this study is up to 3 years Participants will make multiple visits to the clinic and 3 months after the End-of-Treatment visit Follow-up is intended to continue for 2 years after the last participants was enrolled into the study
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1196-8246 | OTHER | WHO | None |
| 2013-002134-21 | EUDRACT_NUMBER | None | None |