Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05525338
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2022-08-26
Brief Title:
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing
Status:
RECRUITING
Status Verified Date:
2024-05
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:
ADAPT ALEC
Brief Summary:
The ADAPT ALEC randomized controlled trial RCT is performed in patients with Anaplastic Lymphoma Kinase ALK positive non-small cell lung cancer NSCLC The RCT will compare the use of Therapeutic Drug Monitoring TDM and dose increases if alectinib 35 ngMl arm A with standard of care arm B
Detailed Description:
The ADAPT ALEC trial is a phase IV RCT in patients with ALK positive NSCLC treated with alectinib A longer median progression free survival mPFS is expected in patients treated with standard dose alectinib when minimum plasma concentrations Cmin of alectinib exceed 435 ngmL The ADAPT ALEC trial will investigate whether using therapeutic drug monitoring TDM and increasing the dose of alectinib in patients with Cmin 435 ngmL will raise the mPFS We will compare mPFS in the subgroup of patients with an alectinib Cmin 435 ngmL using TDM and dose increases arm A to fixed dosingstandard of care arm B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| NL9411 | REGISTRY | Nederlands Trial Register | None |
| 2020-001737-13 | EUDRACT_NUMBER | None | None |