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A clinical trial to look at how safe alectinib is, and how well it works in children and adolescents who have a tumor in the brain and/or spinal cord or a solid tumor somewhere else in the body that contains a specific change in the ALK gene called ALK-fusion that either did not get better with previous treatment or for whom there is no current treatment available
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
- Cancer
- Brain Tumor
- CNS Tumors
- Solid Tumors
- ALK Fusion-positive Solid Tumors
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Recruiting
This trial runs in
Cities
- Ann Arbor
- bei-jing-shi
- Cincinnati
- Genova
- København
- London
- Lyon
- Madrid
- Marseille
- Memphis
- Milano
- Montréal
- New York
- Newcastle upon Tyne
- Palo Alto
- Paris
- Parkville
- Randwick
- Seoul
- shang-hai-shi
- St. Petersburg
- Torino
- Toronto
- València
Trial Identifier:
NCT04774718 2020-004239-25 GO42286
Trial Summary
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT04774718,GO42286,2020-004239-25
Trial Identifier
All
Gender
≤ 17 Years
Age
No
Healthy Volunteers
1. How does the GO42286 clinical trial work?
The clinical trial is recruiting children and adolescents aged up to 18 years who have a tumor in the body or in the brain and/or spinal cord that contains an ALK gene fusion. The patients must also have previously received treatment that did not work or have no other treatment options available to them.
The trial is split into three parts. In Part 1, the aim of the trial is to confirm the appropriate dose of alectinib for use in children and adolescents. In Part 2 of the trial, the dose identified in Part 1 will be tested in a new set of patients to see how well it works and how safe it is for children and adolescents. If it is found to work well, more children and adolescents will be tested in Part 3.
2. How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be younger than 18 years old and have a solid tumor in your body or brain and/or spinal cord that contains an ALK gene fusion. You must also have previously received treatment that did not work or have no other treatment options available.
You must not have any conditions of the bowel that prevent you from absorbing medications taken by mouth. You must also not have previously taken any medications that work against the ALK gene fusion. If you have taken certain other medications within a particular timeframe, you may not be able to take part. If you are pregnant or breastfeeding you will not be able to take part.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, you will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
3. What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will take alectinib as a capsule, by mouth, twice a day (morning and evening) with food. For patients who struggle to swallow full capsules, alectinib can be given as a suspension to drink, or in some circumstances, through a feeding tube.
Part 1
If you join the trial in Part 1, you will take alectinib twice a day. You will be given a starting dose on Day 1, but the dose may change as doctors monitor drug levels in your blood during the treatment period.
By the end of Part 1, doctors will have confirmed the dose of alectinib for patients to take in Parts 2 and 3.
Parts 2 and 3
If you join the trial in Part 2 or 3, you will receive a dose of alectinib based on your age and body weight, which was confirmed in Part 1. You will take this dose twice a day.
4. How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment alectinib for up to 5 years, but you may be able to continue treatment for longer. You are free to stop this treatment at any time. During treatment, you will have scans of your tumor every 8 to 12 weeks to see how you are responding to the treatment and other regular checks to see if you are experiencing any side effects. After stopping treatment with alectinib, you will be seen by a clinical trial doctor in the clinic within 28 days, and may be asked to return for further follow-up visits or be contacted by telephone approximately every 3 months.
5. What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov
Trial-identifier: NCT04774718
Trial Summary
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT04774718,GO42286,2020-004239-25
Trial Identifier
Alectinib
Treatments
ALK Fusion-positive Solid or CNS Tumors
Condition
Official Title
A Phase I/II open-label, multicenter study evaluating the safety, pharmacokinetics, and efficacy of alectinib in pediatric patients with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory treatment available
Eligibility Criteria
All
Gender
≤ 17 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically confirmed diagnosis of CNS or solid tumors harboring ALK gene fusions as determined locally by an appropriately validated assay performed in a CLIA-certified or equivalently-accredited diagnostic laboratory, or centrally by a Foundation Medicine Clinical Trial Assay (CTA) or the alternative, approved central laboratory for that region
- Disease status: prior treatment proven to be ineffective (i.e. relapsed or refractory), or for whom there is no satisfactory standard treatment available. 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)
- Available tumor tissue for submission to the Sponsor from active disease, obtained subsequent to last anti-cancer therapy regiment administered and obtained prior to study enrollment, or willingness to undergo a core or excisional biopsy sample collection prior to enrollment
- For participants < 16 years old, Lansky Performance Status >/= 50%
- For participants >/= 16 years old, Karnofsky Performance Status >/= 50%
- Adequate bone marrow function as defined by the protocol within at least 28 days prior to initiation of study drug
- Participant and/or caregiver willingness and ability to complete clinical outcome assessments throughout the study using either electronic, paper, or interviewer methods
- For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined by the protocol
- 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
Exclusion Criteria
- Medical history of: prior use of ALK inhibitors; any gastrointestinal disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection; history of organ transplant; stem cell infusions as defined by the protocol
- Substance abuse within 12 months prior to screening
- Familial or personal history of congenital bone disorders, bone metabolism alterations, or osteopenia
- Treatment with investigational therapy 28 days prior to initiation of study drug
- Liver or kidney disease as defined by the protocol
- National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade >/=3 toxicities attributed to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with alectinib
- Co-administration of anti-cancer therapies other than those administered in this study
- Active hepatitis B or C virus (HBV, HBC), or known HIV-positivity or AIDS-related illness
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the participant in this study
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; such conditions should be discussed with the participant before trial entry
- Planned procedure or surgery during the study except as permitted treatment as defined by the protocol
- Infection considered by the investigator to be clinically uncontrolled or of unacceptable risk to the participant upon induction of neutropenia, including participants who are, or should be, on antimicrobial agents for the treatment as active infection
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
For the latest version of this information please go to www.forpatients.roche.com