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

Phase 2

Recruiting

• Conditions: 12 months to 15 year- old patients with unresectable or refractory solid cancer with BRAF V600

• Registration Number: JPRN-jRCTs011220017
• Lead Sponsor: Kinoshita Ichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed response rate based on RECIST version 1.1 up to 24 weeks after initiation of treatment in the patients with measurable disease

Secondary Outcome Measures

Name	Time	Method
Confirmed response rate based on RECIST version 1.1 in the patients with measurable disease<br>Best percent change in the sum of diameters of measurable lesions evaluated according to RECIST version 1.1<br>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<br>Response rate based on RANO for the patients with primary brain tumors<br>Proportion of disease control, progression free survival, and overall survival, including patients with measurable disease and them without measurable disease<br>adverse events