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ALK Inhibitor

Alectinib for Pediatric Brain Cancer

Phase 1 & 2

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 males who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm, as defined by the protocol

Disease should be measurable and evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or Response Assessment in Neuro-oncology criteria (RANO) +/- bone marrow criteria for primary CNS tumors or International Neuroblastoma Response Criteria (INRC)

Must not have

Planned procedure or surgery during the study except as permitted treatment as defined by the protocol

Familial or personal history of congenital bone disorders, bone metabolism alterations, or osteopenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if the drug alectinib is safe and effective in children and adolescents with advanced solid tumors or brain tumors.

Who is the study for?

This trial is for children and adolescents with ALK fusion-positive brain or solid tumors that haven't responded to previous treatments or have no other satisfactory treatment options. Participants must be in a certain health status, agree to use contraception if of childbearing potential, and not have any conditions that could interfere with the study.

What is being tested?

The trial is testing Alectinib's safety, how it's processed by the body (pharmacokinetics), and its effectiveness in treating pediatric patients with specific types of tumors. It includes those who've had ineffective prior treatments or lack standard treatment options.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions to cancer medications such as nausea, fatigue, liver issues, muscle pain, and possibly more serious complications like infections due to weakened immune systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to not have sex or use birth control and not donate sperm as per the study's rules.

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My cancer's progress can be measured using specific medical criteria.

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I am 16 or older and can do most of my daily activities.

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My tumor is confirmed to have ALK gene changes.

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I am under 16 and can do most activities without help.

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My previous treatments did not work, or there are no good standard treatments for me.

Exclusion Criteria

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

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I am not planning any surgeries during the study, except those allowed by the study.

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I have a family or personal history of bone disorders or weak bones.

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I have liver or kidney disease as defined by my doctor's guidelines.

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

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I do not have active hepatitis B or C, and I am not HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 119 Patients • NCT02604342

21%

Constipation

16%

Anaemia

14%

Oedema peripheral

14%

Myalgia

13%

Back pain

12%

Asthenia

12%

Dyspnoea

10%

Cough

Decreased appetite

Upper Respiratory Tract Infection

Blood bilirubin increased

Pneumonia

Diarrhoea

Fatigue

Headache

Abdominal Pain

Blood Creatinine Increased

Bronchitis

Arthralgia

Electrocardiogram QT Prolonged

Nasopharyngitis

Nausea

Pyrexia

Vomiting

Dizziness

Acute kidney injury

Musculoskeletal Chest Pain

Pain in extremity

Tinnitus

Jaw fracture

Ankle fracture

Depression

Blood creatine phosphokinase increased

Deep vein thrombosis

Cholelithiasis

Haemoptysis

Syncope

Abscess jaw

Skull fractured base

Paraesthesia

Death

Myocardial infarction

Cerebellar ataxia

Osteoporotic fracture

Invasive ductal breast carcinoma

Diverticulitis

Erysipelas

H1N1 Influenza

Pharyngitis

Wound Complication

Neuropathy peripheral

Alopecia

Epilepsy

Abdominal pain

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Experimental: Alectinib

Active Comparator: Premetrexed/Docetaxel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ALK-Fusion PositiveExperimental Treatment1 Intervention

Part 1 is a dose-confirmation phase to confirm the recommended phase 2 dose (RP2D). In Parts 2 and 3, participants will receive alectinib at the RP2D on Days 1-28 of each 28-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alectinib

2019

Completed Phase 3

~2810

0 / 11Eligibility criteria met