Last updated 11 months ago
Alectinib Pharmacokinetic in Patients With NSCLC
45 patients around the world
Available in Mexico
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.
Instituto Nacional de Cancerologia de Mexico
1Research sites
45Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Both sexes≥ 18 years oldPathologically confirmed diagnosis of NSCLCStage 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 1.1Symptomatic 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 consentAdequate organ function (hematological, liver, and renal function)Life expectancy of at least 12 weeks
- Carcinomatous meningitis confirmed by a positive CRL cytology or highly suspicious brain MRI.Previous malignancies except for any carcinoma in-situTreatment with other anti-cancer therapyParticipating in other clinical trials in the former four weeksAny 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.
Sites
Instituto Nacional de Cancerología - Ciudad de México
Recruiting
SponsorInstituto Nacional de Cancerologia de Mexico
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05713006
