12 months to 15 year- old patients with unresectable or refractory solid cancer with BRAF V600
Conditions
Interventions
Dabrafenib capses are administered orally twice daily according to the package insert. Dabrafenib dispersible tablets are administered orally twice daily at doses based on body weight and age.
Tramet
Sponsors
Kinoshita Ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 12 months to 15 years 2) Patients are diagnosed with pediatric solid cancer (including histiocytosis, not including colorectal cancer) by JCCG central review or Implementation facility 3) Patients are diagnosed with solid cancers with BRAF V600 by comprehensive genome profiling. In the patients with histiocytosis, BRAF V600E mutation was confirmed by JCCG central review 4) recurrent, unresectable or refractory solid cancer 5) PS :0 to 2 6) Patients do not receive chemotherapy or radiotherapy at the registration 7) more than 7 days since the completion of radiotherapy 8) meet the inspection value within 14 days of the registration. 9)Patient agree the study
Exclusion criteria
Exclusion criteria: 1) having other cancers 2) having infections 3) having fever, over 38.0 4) during pregnancy 5) Patients administered immunosuppressive agents 6) Patients administered BRAF inhibitor or MEK inhibitor 7) Patients administered concomitant prohibited drugs 8) Patients received allogeneic hematopoietic stem cell transplantation within 3 months. 9) having daiabetes mellitus 10) having congestive heart failure within 3 months. 11) having cancers with RAS pathway activation or BRAF-KIAA1549 fusion 12) HIV antibody positive 13) A history of infection with HBV or HCV. However, patients negative for HBsAg, positive for HBsAb or HBcAb, with HBV-DNA below detection limits, may be eligible. Similarly, those positive HCV Ab, with HCV-RNA below detection limits, may also be eligible. 14) having retinal vein occlusion or central serous chorioretinal vein retinopathy 15) Responsible investigator or investigator considers ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed response rate based on RECIST version 1.1 up to 24 weeks after initiation of treatment in the patients with measurable disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed response rate based on RECIST version 1.1 in the patients with measurable disease Best percent change in the sum of diameters of measurable lesions evaluated according to RECIST version 1.1 Response rate based on RECIST version 1.1 for study subjects with measurable disease, replacing RANO based best overall response for the patients with primary brain tumors with measurable disease Response rate based on RANO for the patients with primary brain tumors In patients with histiocytosis, transition of clinical score for disease activity (DAS) In patients with histiocytosis, response rate according to Histiocyte Society assessment guidelines. Proportion of disease control, progression free survival, and overall survival, including patients with measurable disease and them without measurable disease adverse events | — |
Contacts
Public ContactShigeru Yamaguchi
Hokkaido University Hospital
Outcome results
None listed