Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
NCT ID: NCT05525338
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
196 participants
INTERVENTIONAL
2022-03-23
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TDM-guided dosing arm
Alectinib
In case of an alectinib plasmaconcentration Cmin \<435 ng/mL, determined by TDM, and manageable toxicity, the alectinib dose will be increased with 150mg BID up to a maximum of 900mg BID. In case of unacceptable toxicity (i.e. unbearable or persistent grade 2 toxicity and grade 3/4 toxicity), the alectinib dose can be reduced by 150mg BID.
Standard dose arm
Alectinib plasmaconcentration will be blinded untill the end of the trial. No intervention based on the alectinib plasmaconcentrion will be performed. In case of unacceptable toxicity (i.e. unbearable or persistent grade 2 toxicity and grade 3/4 toxicity), the alectinib dose can be reduced by 150mg BID.
No interventions assigned to this group
Interventions
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Alectinib
In case of an alectinib plasmaconcentration Cmin \<435 ng/mL, determined by TDM, and manageable toxicity, the alectinib dose will be increased with 150mg BID up to a maximum of 900mg BID. In case of unacceptable toxicity (i.e. unbearable or persistent grade 2 toxicity and grade 3/4 toxicity), the alectinib dose can be reduced by 150mg BID.
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-4
* Histologically or cytology confirmed NSCLC
* Documented ALK rearrangement based on an EMA approved test
* Patients can either be chemotherapy-naïve or have received one line of platinum-based chemotherapy
* Patients with brain or leptomeningeal metastases are allowed on the study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks without steroid treatment. Patients who do not meet these criteria are not eligible for the study
* Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment
* Signed writte Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures
* Observational other studies are allwoed for patients included in this study
* Local radiotherapy is allowed for pain
Exclusion Criteria
* Consumption of agents which modulate CYP3A4 or agents with potential QT prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions)
* Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the subject in this study.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
18 Years
ALL
No
Sponsors
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Amsterdam University Medical Center
OTHER
Erasmus Medical Center
OTHER
Maastricht University Medical Center
OTHER
Radboud University Medical Center
OTHER
The Netherlands Cancer Institute
OTHER
Leiden University Medical Center
OTHER
University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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A.J. van der Wekken, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Gustave Roussy
Villejuif, Val-de-Marne, France
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center +
Maastricht, Limburg, Netherlands
The Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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B. Besse, PhD
Role: primary
M.M. van den Heuvel, PhD
Role: primary
L.E.L. Hendriks, PhD
Role: primary
A.J. de Langen, PhD
Role: primary
S.M.S. Hashemi, Msc
Role: primary
E.F. Smit, PhD
Role: primary
A.C. Dingemans, PhD
Role: primary
A.J. van der Wekken, PhD
Role: primary
References
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Meertens M, Muntinghe-Wagenaar MB, Sikkema BJ, Lopez-Yurda M, Retel VP, Paats MS, Ter Heine R, Schuuring E, Timens W, Touw DJ, van Boven JFM, de Langen AJ, Hashemi SMS, Hendriks LEL, Croes S, van den Heuvel MM, Dingemans AC, Mathijssen RHJ, Smit EF, Huitema ADR, Steeghs N, van der Wekken AJ. Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC). Front Oncol. 2023 Mar 9;13:1136221. doi: 10.3389/fonc.2023.1136221. eCollection 2023.
Other Identifiers
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2020-001737-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL9411
Identifier Type: REGISTRY
Identifier Source: secondary_id
202000251
Identifier Type: -
Identifier Source: org_study_id
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