Actively Recruiting
Alectinib Pharmacokinetic in Patients With NSCLC
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2026-04-08
45
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alectinib Pharmacokinetic in Patients With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both sexes
- 18 years old or older
- Pathologically confirmed non-small cell lung cancer
- Stage IIIB to IV disease
- Recurrent disease at least 180 days after curative treatment
- ALK rearrangement confirmed by FDA-approved tests
- Karnofsky performance status of 70% or higher
- Prior treatment with anti-ALK inhibitors and one line of platinum-based chemotherapy
- Measurable disease by RECIST version 1.1
- Symptomatic brain metastases treated with radiotherapy or surgery at least two weeks before treatment
- Asymptomatic brain metastases without prior local therapy
- Negative pregnancy test within 72 days before first dose
- Use of effective contraception if sexually active
- Signed informed consent
- Adequate blood, liver, and kidney function
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Carcinomatous meningitis confirmed by cerebrospinal fluid cytology or suspicious brain MRI
- Previous cancers except carcinoma in situ
- Current treatment with other anti-cancer therapies
- Participation in other clinical trials within the last four weeks
- Serious conditions, uncontrolled infections, altered mental status, or psychiatric conditions limiting study participation
- Active hepatitis infection or chronic infection with risk of reactivation
- Active HIV infection
- Breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Research Team
O
Oscar G Arrieta Rodriguez, M.D., M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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