Solid Tumors Clinical Trial
Official title:
An Open-Label, Phase 1/2 Dose Escalation and Expansion Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Brigatinib as Monotherapy in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate formulation [AAF]) administered orally once daily (QD) in pediatric and young adult participants in Phase 1 and to define the efficacy of brigatinib administered as monotherapy within the disease-specific expansion arms (unresectable/recurrent anaplastic lymphoma kinase positive (ALK+) inflammatory myofibroblastic tumor (IMT); relapsed/refractory ALK+ anaplastic large cell lymphoma (ALCL) in Phase 2.
The drug being tested in this study is called Brigatinib. Brigatinib is being tested to treat
people who have Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other
solid tumours.
The study will enroll approximately 61 patients. Participants will be assigned to the
following arm group to receive brigatinib:
- Phase 1 (Dose Escalation): Brigatinib Dose Level 1 and Dose Level 2 (based on safety and
tolerability)
- Phase 2 (Dose Expansion): Unresectable/ Recurrent ALK+ IMT
- Phase 2 (Dose Expansion): Relapsed/ Refractory ALK+ ALCL
All participants will be administered brigatinib orally once daily in 28-day Cycles.
Participants will receive fixed doses of brigatinib based on weight ranges. The starting
doses in Phase 1 (Dose Level 1) are expected to provide systemic exposures of brigatinib in
pediatric participants comparable to those achieved in adults receiving the recommended
clinical dose of 90 mg once daily for 7 days followed by 180 mg once daily. One additional
dose level (Dose Level 2) is planned in Phase 1 if the initial dose level is tolerated. This
subsequent dose level is expected to provide systemic exposures of brigatinib in pediatric
participants comparable to those achieved in adults receiving 90 mg once daily for 7 days
followed by 240 mg once daily (the highest acceptably tolerated dose in adults). In Phase 2,
brigatinib will be administered at the RP2D determined during Phase 1.
This multi-centre trial will be conducted worldwide. The overall time to participate in this
study is approximately 36 months. Participants will make multiple visits to the clinic and
will be contacted by telephone OR a final visit after receiving their last dose of brigatinib
for a follow-up assessment.
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