Dabrafenib and Trametinib in pediatric patients with refractory advanced Solid Tumors with BRAF V600 mutations

Kinoshita Ichiro0 个研究点目标入组 28 人开始时间: 2022年9月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) 12 months to 15 years
•2) Patients are diagnosed with pediatric solid cancer by JCCG central review or Implementation facility
•3) Patients are diagnosed with solid cancers with BRAF V600 by comprehensive genome profiling.
•4) 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

•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

发起方

Kinoshita Ichiro