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Alectinib Pharmacokinetic in Patients With NSCLC

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllInstituto Nacional de Cancerologia de Mexico
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In plain words

What the trial is, and whether it could suit you

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 (

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📋 Eligibility rules (as published)
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 FISH) * Karnofsky PS scale ≥ 70% * Having received first-line treatment with anti-ALK inhibitors and one previous line of platinum-based chemotherapy. * Measurable disease as referred by RECIST version 1.1 * Symptomatic brain metastases could receive prior treatment with radiotherapy or surgery for at least two weeks before treatment initiation. * Asymptomatic brain metastases could not receive local therapy before study inclusion. * Negative highly sensitive pregnancy test (serum or urine) within 72 days before first dose intervention. * Sexually active patients should use a contraceptive method with a failure rate of less than 1% per year. * Signed written informed consent * Adequate organ function (hematological, liver, and renal function) * Life expectancy of at least 12 weeks Exclusion Criteria: * Carcinomatous meningitis confirmed by a positive CRL cytology or highly suspicious brain MRI. * Previous malignancies except for any carcinoma in-situ * Treatment with other anti-cancer therapy * Participating in other clinical trials in the former four weeks * Any other serious condition or uncontrolled active infection, altered mental status, or psychiatric condition that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results. * Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel. * Active HIV infection. * Breastfeeding.
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What it tests

  • Alectinib Oral Product
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Where

1 site
Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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