Recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma. Recurrent or refractory neuroblastoma
Conditions
Interventions
A multicenter, single group assignment, open label, phase I dose-escalation study followed by a phase II study. This drug should be orally administered twice a day. It should be repeatedly administer
Sponsors
St. Marianna University School of Medicine Hospital National Center for Child Health and Development Nagoya Medical Center Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Phase 1/2 parts] 1)Patients aged 1 to 21 years on obtaining informed consent. 3)Patients whose histopathology tissues or slides of lymphoma can be provided for central review. 5)Patients aged over17 years with a Karnofsky performance status of 50 to 100% or those aged under16 years with a Lansky performance status of 50 to 100%. 6)Patients fully recovered from the acute toxic effects of all prior anti-cancer therapy, and enough periods defined in the protocol must have elapsed since the completion of each prior therapy. 7)Patients who fulfill the organ function requirement defined in the protocol. [Phase 1 part] 2)Patients with recurrent/refractory ALK(+)ALCL or recurrent/refractory neuroblastoma, histologically confirmed at original diagnosis or relapse. 4)Patients with ALK(+)ALCL having measurable or evaluable disease, or patients with neuroblastoma having measurable tumor on MRI, CT, or plain X-ray or evaluable lesions by MIBG scintigraphy and/or bone marrow involvement with tumor cells seen on routine morphology. [Phase II part] 2)Patients with recurrent/refractory ALK(+)ALCL histologically confirmed at original diagnosis or relapse. 4)Patients having measurable disease.
Exclusion criteria
Exclusion criteria: [Phase 1/2 parts] 1) Patients with CNS (central nervous system)disease. 2) Primary cutaneous ALCL. 3) Pregnant or brest-feeding women. 4) Patients of reproductive potential who have not agreed to use an effective contraception method. 5) Patients receiving the following concomitant medications 5-1) Therapeutic corticosteroids for lymphoma 5-2) investigational instruments and clinical trial products. 5-3) Anticancer agents 5-4) narrow therapeutic indice CYP3A4 substrates 5-5) Strong CYP3A4 inhibitors 5-6) Strong CYP3A4 inducers 6) Patients with interstitial fibrosis or interstitial lung disease or with a known history of those. 7) Patients with myocardial infarction or cerebrovascular disorder or with a known history of those. 8) Patients having an uncontrolled infectious disease. 9) Those who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. 10) Patient who can not take capsule formulation or liquid formulation. However, administration of the liquid preparation via the feeding tube is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Phase 1 part] Dose-limiting toxicity [Phase 2 part] Response rate evaluated by the Central Evaluation Committee | — |
Secondary
| Measure | Time frame |
|---|---|
| [Phase 1 part] Pharmacokinetics Adverse events Response rate evaluated by the investigators [Phase 2 part] Complete remission rate Response period Progression-free survival [PFS] Event-free survival [EFS] Adverse events | — |
Countries
Japan
Contacts
Public ContactYutaka Ito
National Hospital Organization Nagoya Medical Center Department of Clinical Research Management, Clinical Research Center
Outcome results
None listed