Actively Recruiting
A Phase I/II Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
Led by Princess Maxima Center for Pediatric Oncology · Updated on 2025-12-05
65
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating brigatinib, a second-generation oral tyrosine kinase inhibitor, in pediatric and young adult patients aged 1 to 25 years with ALK-positive anaplastic large cell lymphoma (ALCL), inflammatory myofibroblastic tumors (IMT), or other solid tumors. This open-label Phase I-II study aims to determine the recommended dose of brigatinib when used alone, and to assess its pharmacokinetics, long-term safety, and effectiveness in these patients. The study has two parts: Phase 1 involves dose escalation using a rolling-6 design to find the maximum tolerated dose or recommended Phase 2 dose, focusing mainly on patients 18 years or younger. Phase 2 expands to evaluate safety and clinical activity in two groups: one with ALK-positive IMT and another with ALK-positive ALCL, with planned sample sizes of 12 and 22 patients respectively. Patients receive brigatinib orally, and dosing decisions consider pediatric pharmacokinetics and toxicity. Participants will be monitored over 2 years, with assessments including evaluation of dose tolerance, drug pharmacokinetics, tumor response by RECIST criteria for IMT, and event-free survival for ALCL. Safety and organ function tests, cardiac monitoring, and pregnancy tests are part of the evaluations. The study also requires adherence to contraception guidelines and follow-up for long-term outcomes to understand brigatinib's role in these cancers.
CONDITIONS
Brief 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 less than 26 years at enrollment, able to swallow brigatinib tablets, and weighing at least 10 kg
- Confirmed cancer diagnosis with ALK-positive status by approved laboratory tests
- For Phase 1, patients with ALCL must be relapsed/refractory or intolerant to standard therapies
- Patients with relapsed/refractory IMT not suitable for curative surgery, or newly diagnosed unresectable ALK+ IMT
- Patients with other solid tumors must have relapsed or refractory disease
- For Phase 2, patients must have measurable or evaluable disease as defined for ALCL and IMT
- Karnofsky or Lansky performance status of 40% or higher
- No other investigational medications within 30 days prior to first dose
- Prior ALK inhibitor treatment allowed except for brigatinib
- Recovery from prior treatment toxicities to Grade less than 2 (except alopecia or neuropathy)
- Specified washout periods after chemotherapy, immunotherapy, biologics, immunosuppressive therapy, and radiotherapy
- Adequate organ function including kidney, liver, bone marrow, and heart function
- Life expectancy of at least 3 months
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and after study participation
- Written informed consent according to laws and regulations
You will not qualify if you...
- Use of strong or moderate CYP3A inhibitors or inducers within 14 days prior to first dose
- Diagnosis of another concurrent primary cancer
- Significant cardiovascular disease including recent myocardial infarction, unstable angina, heart block, or severe arrhythmias
- Uncontrolled hypertension despite treatment
- Planned chemotherapy, radiation, investigational agent, or immunotherapy while on study
- Illness affecting gastrointestinal absorption
- Active systemic infection, HIV, or hepatitis B or C infection
- Any condition compromising safety or study evaluation as judged by investigator
- History of cerebrovascular disease with unresolved deficits
- Uncontrolled seizure disorder requiring medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive brigatinib as monotherapy to evaluate the recommended dose, pharmacokinetics, safety, and efficacy for ALK+ ALCL, IMT, or other solid tumors.
Visits scheduled according to dose-escalation and expansion protocol
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
G
Gertruud Bakker
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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