Alectinib + Crizotinib for Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.
Will I have to stop taking my current medications?
The trial requires that you do not take strong cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days before starting and during treatment with crizotinib. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Alectinib and Crizotinib for cancer?
Alectinib has been shown to be effective in treating advanced ALK-positive non-small cell lung cancer (NSCLC), especially in patients who have not responded to Crizotinib. Studies have demonstrated that Alectinib improves progression-free survival and has a good safety profile, making it a promising option for patients with this type of cancer.12345
Is the combination of Alectinib and Crizotinib safe for humans?
Alectinib and Crizotinib have been studied for safety in patients with ALK-positive non-small-cell lung cancer. Alectinib generally has a manageable safety profile, with most side effects being mild or moderate, such as liver issues and reduced white blood cell counts. Crizotinib has been compared to Alectinib, with Alectinib showing a favorable safety profile.15678
How is the drug combination of Alectinib and Crizotinib unique for cancer treatment?
The combination of Alectinib and Crizotinib is unique because Alectinib is a highly selective ALK inhibitor that has shown improved progression-free survival and better central nervous system outcomes compared to Crizotinib alone in ALK-positive non-small cell lung cancer (NSCLC). This combination may offer enhanced efficacy, especially for patients with brain metastases.1591011
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for patients with ALK- or RET-positive cancer who were part of a previous Roche-sponsored alectinib study and are still benefiting from alectinib or crizotinib. They must not be able to switch to commercial supply, agree to contraception if necessary, and cannot join if they're pregnant, breastfeeding, had no benefit in the parent trial, experienced severe side effects that led to discontinuation, or have unresolved serious adverse events.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive continued treatment with alectinib or crizotinib as applicable, following the same dose and schedule as in the parent trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Alectinib
- Crizotinib
Alectinib is already approved in United States, European Union for the following indications:
- Metastatic ALK-positive non-small cell lung cancer (NSCLC)
- Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC
- Metastatic ALK-positive non-small cell lung cancer (NSCLC)
- Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University