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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06159478
Other study ID # NCCH2101/MK011
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 29, 2023
Est. completion date September 30, 2027

Study information

Verified date December 2023
Source National Cancer Center, Japan
Contact Chigusa Morizane, M.D., Ph.D.
Phone 0335422511
Email ncch2101_office@ml.res.ncc.go.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion/rearrangement.


Description:

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial. Eligible patients are with recurrent low-grade glioma (grade 1 and grade 2 tumors according to WHO classification) or advanced or recurrent pancreatic cancer harboring BRAF fusion/rearrangement. Patients receive binimetinib 45mg administered orally, twice daily. Analyses will be performed on each of the two cohorts: Cohort A: low-grade glioma Cohort B: pancreatic cancer


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Study Design


Intervention

Drug:
Binimetinib 15 MG
Binimetinib 45mg is orally administered twice daily.

Locations

Country Name City State
Japan National Cancer Center Japan Chuo-ku Tokyo
Japan Kyushu University Hospital Fukuoka
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan Kyoto University Hospital Kyoto City Kyoto
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Tohoku university Hospital Sendai Miyagi

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Center, Japan Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (centrally assessed) Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment. Baseline up to 4 years
Secondary Overall response rate (investigator assessed by RECIST) Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be performed by investigator assessment. Baseline up to 4 years
Secondary Overall response rate (investigator assessed by RANO) Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment. Baseline up to 4 years
Secondary Overall response rate including minor response(investigator assessed by RANO) Overall response rate (ORR) defined as the combined incidence of complete response (CR) PR and SD, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment. Baseline up to 4 years
Secondary Progression-free survival Progression-free survival (PFS) defined as the time from the date of enrollment to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first within cohort A FAS and cohort B FAS. Baseline up to 4 years
Secondary Overall survival Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause within cohort A FAS and cohort B FAS. Baseline up to 4 years
Secondary Disease control rate Disease control rate (DCR) defined as the percentage of patients with a confirmed complete response (CR), partial response (PR) or stable disease (SD) as the best overall according to RECIST version 1.1 within cohort A FAS and cohort B FAS. Baseline up to 4 years
Secondary Duration of response Duration of Response (DOR) defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first within cohort A FAS and cohort B FAS. Baseline up to 4 years
Secondary Adverse event rate Defined as the percentage of patients who experienced each adverse event. The severity of AEs were evaluated by the investigator according to Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0-JCOG) within cohort A FAS and cohort B FAS. Baseline up to 4 years
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