Actively Recruiting
Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-12-05
65
Participants Needed
2
Research Sites
589 weeks
Total Duration
On this page
Sponsors
P
Princess Maxima Center for Pediatric Oncology
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.
CONDITIONS
Official Title
Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 to under 26 years who can swallow brigatinib tablets and weigh at least 10 kg
- Confirmed cancer diagnosis by histology with activating ALK aberration in tumor
- For ALK+ ALCL, relapsed/refractory or intolerant to standard therapies; for IMT, unresectable or relapsed/refractory ALK+ IMT
- For phase 1, patients with relapsed/refractory ALCL, IMT, or other solid tumors as specified
- For phase 2, patients must have measurable or evaluable disease and relapsed/refractory status as defined
- Karnofsky or Lansky performance status of 40% or higher depending on age
- No investigational medications within 30 days prior to study drug start
- Previous ALK inhibitor treatment allowed except brigatinib
- Recovery to Grade <2 or baseline from prior therapy toxicities (except alopecia and peripheral neuropathy)
- Specified washout periods from chemotherapy, immunotherapy, biologics, immunosuppressives, and radiotherapy
- Adequate organ function including kidney, liver, blood counts, cardiac function, and normal QT interval
- Life expectancy of at least 3 months
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and after the study
- Voluntary written informed consent according to regulations
You will not qualify if you...
- Use of strong or moderate CYP3A inhibitors or inducers within 14 days or five half-lives before first dose
- Diagnosis of another concurrent primary cancer
- Significant cardiovascular disease including recent myocardial infarction, unstable angina, heart block, arrhythmias, or uncontrolled hypertension
- Planned chemotherapy, radiation, investigational agents, or immunotherapy not per protocol while on study
- Any illness affecting gastrointestinal absorption
- Active systemic infection, HIV, or hepatitis B or C infection
- Any condition that may compromise safety or interfere with study evaluation
- History of cerebrovascular ischemia or hemorrhage with residual deficits
- Uncontrolled seizure disorder (well-controlled seizure disorders allowed)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institut Gustave Roussy
Paris, France, 94805
Actively Recruiting
2
Princess Máxima Center for Pediatric Oncology
Utrecht, Utrecht, Netherlands, 3584 CS
Actively Recruiting
Research Team
M
Maaike Boonstra
CONTACT
G
Gertruud Bakker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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