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.
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