Alectinib Pharmacokinetic in Patients With NSCLC

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 pharmacokinetic evaluation (phase I) in Mexican patients with advanced ALK-rearranged NSCLC? In phase I (on days 0, 21, and 42), oral alectinib will be administered twice per day (BID) to patients with ALK-posit

Trial Details

NCT ID

NCT05713006

Phase

PHASE1 / PHASE2

Sponsor

Instituto Nacional de Cancerologia de Mexico

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

• Alectinib Oral Product

Locations (sample)

• Mexico City, Mexico City, Mexico|19.42847,-99.12766

Key Eligibility Criteria

• Both sexes
• ≥ 18 years old
• Pathologically confirmed diagnosis of NSCLC
• Stage IIIB - IV by the American Joint Committee of Cancer Version 8.

For full eligibility, visit ClinicalTrials.gov.

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