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NCT Number: NCT05713006

Alectinib Pharmacokinetic in Patients With NSCLC

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.

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Key information

Conditions

Non-Small Cell Lung Cancer Stage IIIB ALK Gene Mutation Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología

Mexico City, 14080, Mexico

Location status: Recruiting

Location contact

Oscar G Arrieta, M.D., M.Sc.

CONTACT

[email protected]

5556280400 ext. 71101

About this study

Alectinib will be administrated under fast conditions.

The primary endpoint of the phase II part was ORR. Other secondary endpoints in phase II are progression-free survival (PFS), overall survival (OS), intracranial response (ICR), and duration of response (DOR).

Exploratory endpoints in this follow-up analysis included the evaluation of the correlation between tumor shrinkage and PFS and chosen dose to relieve cancer symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alectinib Oral Product

Drug

Alectinib is administered with a sequential dose escalation every 21 days from 300 to 600mg twice daily in the phase 1 portion. In phase 2, patients received an investigator-chosen dose based on the PK analysis.

Other names: Alecensa 150 mg Roche

Primary outcomes

  1. AUC

    Time frame: Amount of drug concentration between 0 to 12 hours after first drug administration

    The area under the curve (AUC). Pharmacokinetic behavior of the initial alectinib for each given dose (300, 450 and 600 mg).

  2. Cmax

    Time frame: From baseline control pre-dose, 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 11.90 hours

    Highest concentration of drug in blood (Serum) for each given dose (300, 450 and 600 mg).

  3. Cmin

    Time frame: From baseline control pre-dose, 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 11.90 hours

    Lowest concentration of drug in blood (Serum) for each given dose (300, 450 and 600 mg).

  4. Tmax

    Time frame: From first dose administration through the following 12 hours (day 1)

    Time in witch Cmax is reached in each dose of the drug (300,450 and 600 mg)

  5. ORR

    Time frame: From first dose administration up to disease progression by CT scan every 6 weeks, through study completion.

    overall response rate is measured in phase two

  6. Steady state

    Time frame: For phase two: between 2 and 4 months of treatment with investigators chosen dose.

    The amount of drug in the plasma has built up to a therapeutically effective concentration level, and as long as regular doses are administered to balance the amount of drug being cleared, the drug will continue to be active.

Secondary outcomes

  1. Adverse events

    Time frame: From date of first dose administration through 9 weeks.

    Tolerance during drug escalation doses (300, 450, and 600 mg) in the phase one portion based on the PK analysis.

  2. Drug toxicity

    Time frame: From date of starting phase 2 portion until the date of first documented progression date or death from any cause, whichever comes first, assessed up to 60 months.

    Adverse events under alectinib Administration a the chosen dose are measured in the phase two portion.

  3. PFS

    Time frame: From date of first dose administration until the date of first documented progression date or death from any cause, whichever comes first, assessed up to 100 months.

    Progression-free survival

  4. OS

    Time frame: From date of first dose administration until the date of documented death from any cause or last follow-up, whichever comes first, assessed up to 120 months.

    overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Oscar G Arrieta Rodriguez, M.D., M.Sc.

CONTACT

[email protected]

5556280400 ext. 71101

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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