Alectinib Pharmacokinetic in Patients With NSCLC

Recruiting Phase 1 Phase 2 Interventional Study
Non-small Cell Lung Cancer Stage IIIB ALK Gene Mutation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Instituto Nacional de Cancerologia de Mexico · Other
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About This Trial
This interventional study aims to determine the pharmacokinetics of orally administered alectinib with dose escalation from 300 mg to 600 mg twice daily in Mexican patients with advanced ALK-positive NSCLC. The main question it aims to answer is: what will be the peak plasma concentrations of alectinib following sequential dose escalation (300, 450, and 600 mg BID) over nine weeks of pharmacokine…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Both sexes * ≥ 18 years old * Pathologically confirmed diagnosis of NSCLC * Stage IIIB - IV by the American Joint Committee of Cancer Version 8. * Recurrent disease (at least 180 days from curative intent treatment) * ALK rearrangements tested by FDA-approved tests (IHQ or FIS…
Contacts

Oscar G Arrieta Rodriguez, M.D., M.Sc.

5556280400

ogar@unam.mx

CONTACT