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Alectinib Pharmacokinetic in Patients With NSCLC

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 1, 2027
    • Site details revised
    v7
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2025v6
  3. Primary completion date: Dec 1, 2023 to Dec 1, 2024v5
  4. Primary completion date: Nov 1, 2023 to Dec 1, 2023v4
  5. Primary completion date: May 1, 2023 to Nov 1, 2023v3
  6. Study title shortened, about 1 wordv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05713006
Lead Sponsor Instituto Nacional de Cancerologia de Mexico
Conditions
(from sponsor)		 Non-small Cell Lung Cancer Stage IIIB, ALK Gene Mutation
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov