Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01449461
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2011-09-30
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase ALKEpidermal Growth Factor Receptor EGFR Inhibitor Brigatinib AP26113
Sponsor:
Ariad Pharmaceuticals
Organization:
Takeda
Study Overview
Official Title:
A Phase 12 Study of the Safety Tolerability Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALKEGFR Inhibitor AP26113
Status:
COMPLETED
Status Verified Date:
2021-07
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 2-fold initially in the dose escalation phase the goal is to determine the safety profile of orally administered brigatinib including the maximum tolerated dose MTD dose limiting toxicities DLTs recommended phase 2 dose RP2D and pharmacokinetic PK profile Then once the RP2D is established an expansion phase will assess the preliminary anti-tumor activity of brigatinib both in non-small cell lung cancer NSCLC with ALK gene rearrangement including participants with active brain metastases or mutated EGFR and in other cancers with abnormal targets against which brigatinib is active
Detailed Description:
The drug being tested in this study is called brigatinib AP26113 Brigatinib is being tested to treat people with NSCLC This study will look at the safety tolerability and efficacy of brigatinib
The study enrolled 137 patients Participants were assigned to one of the following treatment groups
Brigatinib 30 mg once daily QD60 mg QD
Brigatinib 90 mg QD
Brigatinib 120 mg QD60 mg twice daily BID
Brigatinib 90 mg QD-180 mg QD
Brigatinib 180 mg QD90 mg BID
Brigatinib 240 mg QD120 mg BID300 mg QD
This multi-center trial will be conducted worldwide The overall expected time to participate in this study is approximately 4 years Participants will make multiple visits to the clinic and 30 days after the End-of-Treatment visit Follow-up is intended to continue for at least 2 years after the initial dose
The study enrolled 137 patients Participants were assigned to one of the following treatment groups
Brigatinib 30 mg once daily QD60 mg QD
Brigatinib 90 mg QD
Brigatinib 120 mg QD60 mg twice daily BID
Brigatinib 90 mg QD-180 mg QD
Brigatinib 180 mg QD90 mg BID
Brigatinib 240 mg QD120 mg BID300 mg QD
This multi-center trial will be conducted worldwide The overall expected time to participate in this study is approximately 4 years Participants will make multiple visits to the clinic and 30 days after the End-of-Treatment visit Follow-up is intended to continue for at least 2 years after the initial dose
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 |
|---|---|---|---|
| U1111-1196-8197 | OTHER | World Health Organization | None |
| 2011-005718-12 | EUDRACT_NUMBER | None | None |