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Tests treatment safety and results for ALK Fusion-positive Solid or CNS Tumors
Official title A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
ClinicalTrials.gov ID: NCT04774718
What this study is testing
What is Alectinib?
Alectinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alk fusion-positive solid or cns tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the...
- Disease status: prior treatment proven to be ineffective (i.e. relapsed or refractory), or for whom there is no satisfactory standard treatment...
- Available tumor tissue for submission to the Sponsor from active disease, obtained subsequent to last anti-cancer therapy regimen administered and...
- For participants \ /= 50%
- For participants \>/= 16 years old, Karnofsky Performance Status \>/= 50%
You likely can't join if
- Medical history of: prior use of ALK inhibitors; diagnosis of Anaplastic Large Cell Lymphoma (ALCL); any gastrointestinal disorder that may affect...
- 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...
See the full eligibility criteria
- Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-existing NGS test results
- 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...
- Available tumor tissue for submission to the Sponsor from active disease, obtained subsequent to last anti-cancer therapy regimen administered and obtained prior to study enrollment (preferred option), or archival tumor...
- For participants \ /= 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
- Medical history of: prior use of ALK inhibitors; diagnosis of Anaplastic Large Cell Lymphoma (ALCL); any gastrointestinal disorder that may affect absorption of oral medications, such as mal-absorption syndrome or...
- 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...
- 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...
- 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...
- 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...
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- St. Petersburg, Florida, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Memphis, Tennessee, United States
- Randwick, New South Wales, Australia
- Parkville, Victoria, Australia
- Barretos, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Beijing, China
- Shanghai, China
- København Ø, Denmark
- Lyon, France
- Marseille, France
- Paris, France
- Heidelberg, Germany
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; St. Petersburg, Florida, United States; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Cincinnati, Ohio, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.