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Tyrosine Kinase Inhibitor
Alectinib + Crizotinib for Cancer
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Awards & highlights
Study Summary
This trial is for cancer patients who have been benefitting from alectinib or crizotinib and want to continue treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The study continues treatment with either alectinib or crizotinib for participants previously enrolled in related trials. It aims to provide these drugs when commercial options aren't available and assess long-term benefits and safety for those still showing improvement.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience similar side effects as observed in the parent trials of alectinib or crizotinib. These could include liver issues, digestive problems, vision changes, muscle pain among others; however individual experiences can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use effective birth control or remain abstinent during and for 3 months after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
Secondary outcome measures
Number and Causes of Death Occurring on Study
Trial Design
2Treatment groups
Experimental Treatment
Group I: CrizotinibExperimental Treatment1 Intervention
Participants will receive crizotinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
Group II: AlectinibExperimental Treatment1 Intervention
Participants will receive alectinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
2015
Completed Phase 3
~2400
Crizotinib
2014
Completed Phase 3
~2370
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,023 Total Patients Enrolled
1 Trials studying Tumors
474 Patients Enrolled for Tumors
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,740 Total Patients Enrolled
2 Trials studying Tumors
1,135 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any severe side effects from previous treatments that haven't improved.I agree to use effective birth control or remain abstinent during and for 3 months after treatment.I stopped taking alectinib or crizotinib before starting the new study drug.I had to stop my cancer treatment for over 3 weeks because of side effects, but now I'm better or stable.I am benefiting from alectinib or crizotinib in a Roche trial but can't switch to commercial supply.I haven't taken strong drugs that affect liver enzymes in the last 14 days.My previous treatment did not improve my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Crizotinib
- Group 2: Alectinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any similar studies to Crizotinib that have been conducted in the past?
"Crizotinib is being trialed in 55 different ongoing studies, 10 of which are in Phase 3. The vast majority of these trials are being conducted in Chippewa Falls, Wisconsin, but there are 8192 total locations running these clinical trials."
Answered by AI
Does Crizotinib have any dangerous side effects?
"Crizotinib has received a safety score of 3. This is because it has passed multiple rounds of clinical trials, meaning that there is a significant body of evidence supporting its efficacy and safety."
Answered by AI
Are new participants being accepted into this clinical trial?
"This particular study has completed recruitment and is no longer enrolling new patients. The trial was posted on 2017-07-05 and last updated on 2022-08-10. For those still looking for open studies, 4044 trials for cancer patients and 55 for Crizotinib are still open and actively recruiting participants."
Answered by AI
How many people will be included in this research project?
"Unfortunately, this particular clinical trial is not looking for new patients at the moment. However, it is worth noting that the study was updated as recently as August 10th, 2022. There are currently 4044 other trials actively recruiting cancer patients and 55 trials for Crizotinib that are actively admitting participants."
Answered by AI
To your knowledge, has anything like this been attempted before?
"There have been 55 Crizotinib clinical trials since 2011. The first, which was sponsored by Pfizer and completed its Phase 1 drug approval in 2011, enrolled 44 participants."
Answered by AI
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