Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer.
Peter N Morcos, Eveline Nueesch, Felix Jaminion...
https://pubmed.ncbi.nlm.nih.gov/29748847Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05713006
A Phase I/II Open-label Clinical Trial to Evaluate the Pharmacokinetics of Alectinib With Sequential Dose Escalation in Patients Diagnosed With ALK-rearranged Advanced Non-small Cell Lung Cancer
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2026-04-08
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetics of alectinib, an oral drug given to Mexican patients with advanced ALK-positive non-small cell lung cancer (NSCLC). The study aims to find out the peak blood concentrations of alectinib as the dose increases from 300 mg to 600 mg twice daily over nine weeks. It also evaluates how well patients respond to the treatment and tracks disease progression and side effects over time. In the first phase, patients take alectinib in increasing doses every 21 days, starting at 300 mg twice daily and moving up in 150 mg steps to 600 mg twice daily. Blood samples are collected before and after doses on specific days to measure drug levels. After this phase, patients continue treatment with the dose chosen based on earlier results until their disease worsens or side effects become unacceptable. This phase also measures the overall response rate to the drug. Participants will have regular assessments including blood tests, imaging scans every six weeks to monitor tumor response, and evaluations of side effects and survival. Researchers will measure drug concentration levels, treatment response, progression-free survival, and overall survival throughout the study. The study lasts several months, with close observation during dose escalation and ongoing follow-up during treatment.
CONDITIONS
Brief Title
Alectinib Pharmacokinetic in Patients With NSCLC
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Both sexes
- 18 years old or older
- Pathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Stage IIIB to IV disease by American Joint Committee of Cancer Version 8
- Recurrent disease at least 180 days from curative intent treatment
- ALK rearrangements confirmed by FDA-approved tests (IHQ or FISH)
- Karnofsky performance status scale 70% or higher
- Received first-line treatment with anti-ALK inhibitors and one previous line of platinum-based chemotherapy
- Measurable disease as defined 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 highly sensitive pregnancy test within 72 days before first dose
- Use of contraceptive methods with failure rate less than 1% per year for sexually active patients
- Signed informed consent
- Adequate organ function (hematological, liver, renal)
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Carcinomatous meningitis confirmed by positive cerebrospinal fluid cytology or suspicious brain MRI
- Previous malignancies except carcinoma in-situ
- Treatment with other anti-cancer therapy
- Participation in other clinical trials within the last four weeks
- Serious conditions or uncontrolled infections, altered mental status, or psychiatric conditions limiting study participation or data interpretation
- Active hepatitis virus infection or chronic infection with risk of reactivation
- Active HIV infection
- Breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to several months depending on study phase and response
Participants receive Alectinib with sequential dose escalation every 21 days in phase 1 and then an investigator-chosen dose in phase 2 based on pharmacokinetic analysis.
Visits every 21 days for dose escalation and additional visits for pharmacokinetic assessments; CT scans every 6 weeks
Follow-up
Duration - Up to 120 months
Participants are monitored for progression-free survival, overall survival, and adverse events after the end of treatment.
Periodic follow-up visits over several years
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
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Research Team
O
Oscar G Arrieta Rodriguez, M.D., M.Sc.
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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Published Research Related To This Trial
Cost-effectiveness of alectinib compared to crizotinib for the treatment of first-line ALK+ advanced non-small-cell lung cancer in France.
Marine Sivignon, Rémi Monnier, Bertrand Tehard...
https://pubmed.ncbi.nlm.nih.gov/31945065Cost Effectiveness of Alectinib vs. Crizotinib in First-Line Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer.
Josh J Carlson, Kangho Suh, Panos Orfanos...
https://pubmed.ncbi.nlm.nih.gov/29488070Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial.
Toyoaki Hida, Hiroshi Nokihara, Masashi Kondo...
https://pubmed.ncbi.nlm.nih.gov/28501140Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer.
Solange Peters, D Ross Camidge, Alice T Shaw...
https://pubmed.ncbi.nlm.nih.gov/28586279