Alectinib Pharmacokinetic in Patients With ALK-rearranged NSCLC
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
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-positive NSCLC; starting with 300 mg BID in 21-day cycles and dose
escalation in 150 mg increments until 600 mg BID. Blood samples will be taken before and
after administration of each dose (on days 1, 22, and 43). The primary endopoints in phase I
will be dose-limiting toxicity (DLT) and PK parameters (Cmax. maximum plasma concentration;
Tmax: time to reach maximum concentration: AUC 1-12: area under plasma ocncentrations-time
curve steady-state concentration). At the end of the last blood collection (at day 43), the
evaluation of each cycle will be at 600 mg, and the participant will be discharged to
continue their treatment on an outpatient basis. Phase one will finish on day 63 of the
study.
In phase II, the chosen BID dose based on the phase I portion will be administrated until
disease progression, development of unacceptable side effects, or withdrawal of consent. The
primary endpoint in phase 2 is the overall response rate (ORR) per RECIST V.1.1.