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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.

Must not have

Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study

Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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I agree to use effective birth control or remain abstinent during and for 3 months after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any severe side effects from previous treatments that haven't improved.

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I haven't taken strong drugs that affect liver enzymes in the last 14 days.

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I stopped taking alectinib or crizotinib before starting the new study drug.

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I had to stop my cancer treatment for over 3 weeks because of side effects, but now I'm better or stable.

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My previous treatment did not improve my condition.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Number and Causes of Death Occurring on Study

Awards & Highlights

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.

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

2019

Completed Phase 3

~2810

Crizotinib

2014

Completed Phase 3

~2960