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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR): Defined as the Proportion of Participants with Complete Response (CR) or Partial Response (PR) on two Consecutive Occasions >/= 4 Weeks Apart, as Determined by Blinded Independent Central Review (BICR)
Incidence of Participants with Dose-Limited Toxicities (DLTs)
Percentage of Participants with Adverse Events
+2 more
Secondary outcome measures
Clinical Benefit Rate (CBR) as Determined by BICR and the Investigator
Confirmed ORR as Determined by the Investigator
Duration of Response (DOR) as Determined by BICR and the Investigator
+3 more

Side effects data

From 2018 Phase 3 trial • 119 Patients • NCT02604342
24%
Fatigue
22%
Alopecia
16%
Asthenia
16%
Nausea
11%
Neutropenia
11%
Myalgia
11%
Decreased appetite
11%
Anaemia
11%
Constipation
11%
Cough
8%
Pruritus Generalised
8%
Pyrexia
8%
Paraesthesia
8%
Arthralgia
8%
Headache
5%
Pain in extremity
5%
Vomiting
5%
Tinnitus
5%
Febrile neutropenia
5%
Musculoskeletal Chest Pain
5%
Back pain
5%
Diarrhoea
5%
Dizziness
5%
Drug Hypersensitivity
5%
Oedema peripheral
5%
Neuropathy peripheral
3%
Gastroenteritis
3%
Abdominal pain
3%
Nasopharyngitis
3%
Stomatitis
3%
Upper Respiratory Tract Infection
3%
Lung infection
3%
Pneumonia bacterial
3%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Comparator: Premetrexed/Docetaxel
Experimental: Alectinib

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
2015
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,090,026 Total Patients Enrolled
1 Trials studying Tumors
474 Patients Enrolled for Tumors
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,201 Previous Clinical Trials
888,898 Total Patients Enrolled
2 Trials studying Tumors
1,135 Patients Enrolled for Tumors

Media Library

Tumors Research Study Groups: ALK-Fusion Positive

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being signed up for this experiment?

"According to the latest information from clinicaltrials.gov, this study is still looking for participants. The listing was first posted on September 14th 2021 and was last updated on November 8th 2022."

Answered by AI

What is the total number of people participating in this experiment?

"The information available on clinicaltrials.gov does show that the research team is actively looking for patients that fit the study's inclusion criteria. This particular trial was first posted on September 14th, 2021 and has since been updated (November 8th, 2022). There are plans to have 42 individuals participate across 10 different hospitals or clinics."

Answered by AI

What findings have researchers uncovered while studying Alectinib's effects?

"Alectinib was first studied in 2014 at Northwestern University's Robert H. Lurie Comp Can Ctr and Northwestern Medicine Development Inst. So far, 12 clinical trials have completed with 26 more ongoing. Many of these current trials are taking place in Palo Alto, California."

Answered by AI

Does this trial pave the way for other similar studies?

"First studied in 2014, Alectinib has undergone a lot of research in the past 7 years. After the first Phase 2 trial involving 676 patients, Genentech, Inc. sponsored another study that resulted in the drug's approval. Now, 26 live studies are being conducted for Alectinib across 559 cities and 59 countries."

Answered by AI

In how many different settings is this experiment being conducted today?

"Children's hospitals in Palo Alto, Ann Arbor, and Houston are all participating in this study, as well as 10 other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
2021. "A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774718.
~19 spots leftby Jun 2026
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