Trial Outcomes & Findings for Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (NCT NCT03973918)
NCT ID: NCT03973918
Last Updated: 2024-10-31
Results Overview
Number of participants from each treatment cohort with response as defined by Response Assessment in Neuro-oncology (RANO) criteria: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-10-31
Participant Flow
Patients were accrued January 2020 -April 30 2022. The trial terminated early due to mandated closed to accrual for all ABTC studies as of 4/30/21. ABTC is closed to accrual and treatment on October 31 2023. The final trial clinical data includes a total of 5 subjects enrolled into the trial. Per original trial design, 56 subjects were required for the primary objective of the trial. The termination of the trial is considered an administrative termination.
1 patient on Treatment Cohort 2 anaplastic PXAs was still on treatment at the time of the mandated stop of treating patients by NCI/CTEP. This patient continues to receive treatment but not on this study.
Participant milestones
| Measure |
Treatment Cohort 1 AA & GBM
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Surgical Arm
Pre-op -14 days: Encorafenib 450mg QD and Binimetinib 45mg BID last dose of both drugs 2hrs prior to surgery
Tumor; research blood; CSF samples
post surgery: Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
0
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment Cohort 1 AA & GBM
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Surgical Arm
Pre-op -14 days: Encorafenib 450mg QD and Binimetinib 45mg BID last dose of both drugs 2hrs prior to surgery
Tumor; research blood; CSF samples
post surgery: Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
pt had to stop treatment on this study but continued treatment off this study
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
Baseline characteristics by cohort
| Measure |
Treatment Cohort 1 AA & GBM
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Surgical Arm
Pre-op -14 days: Encorafenib 450mg QD and Binimetinib 45mg BID last dose of both drugs 2hrs prior to surgery
Tumor; research blood; CSF samples
post surgery: Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
n=1 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
75 years
n=7 Participants
|
—
|
26 years
n=4 Participants
|
38 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Karnofsky Performance Status Scale
100-80
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Karnofsky Performance Status Scale
70-60
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers
Number of participants from each treatment cohort with response as defined by Response Assessment in Neuro-oncology (RANO) criteria: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
Outcome measures
| Measure |
Treatment Cohort 1 AA & GBM
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
n=1 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|
|
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Complete Response (CR)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Partial Response (PR)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Stable Disease (SD)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Tumor Radiographic Response Per RANO for 3 Treatment Cohorts
Progression Disease (PD)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Each row represents a specific patient. the number in that row equals the progression free survival for a specific patient, as there were only 5 patients Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers
Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status
Outcome measures
| Measure |
Treatment Cohort 1 AA & GBM
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
n=1 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|
|
Progression Free Survival for 3 Treatment Cohorts
pt 1: progression free survival
|
—
|
33.5 months
|
—
|
|
Progression Free Survival for 3 Treatment Cohorts
pt 2: progression free survival
|
—
|
1.7 months
|
—
|
|
Progression Free Survival for 3 Treatment Cohorts
pt 3: progression free survival
|
—
|
—
|
4.2 months
|
|
Progression Free Survival for 3 Treatment Cohorts
pt 4: progression free survival
|
9.3 months
|
—
|
—
|
|
Progression Free Survival for 3 Treatment Cohorts
pt 5: progression free survival
|
10 months
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers Each row represents a specific patient. the number in that row equals the overall survival for a specific patient, as there were only 5 patients
overall survival in months. Specific survival for each patient due to early termination
Outcome measures
| Measure |
Treatment Cohort 1 AA & GBM
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
n=1 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|
|
Overall Survival
pt number 1
|
—
|
33.9 months
|
—
|
|
Overall Survival
pt number 2
|
—
|
5.1 months
|
—
|
|
Overall Survival
pt number 3
|
—
|
—
|
4.2 months
|
|
Overall Survival
pt number 4
|
10.7 months
|
—
|
—
|
|
Overall Survival
pt number 5
|
12.4 months
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearPopulation: Each row represents the type of response. The number in that row equals the duration of response in months (mean) for all patients in cohort who had a response of the row title. There were 5 patients and only 3 patients had a response of CR or PR
Time from response to progression. Response is defined by RANO: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
Outcome measures
| Measure |
Treatment Cohort 1 AA & GBM
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
n=2 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
n=1 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|
|
Duration of Response - Complete and Partial
Duration of Partial response (PR) from baseline months
|
8.5 months
|
8 months
|
—
|
|
Duration of Response - Complete and Partial
Duration of Complete response (CR) from base line in months
|
—
|
34 months
|
—
|
|
Duration of Response - Complete and Partial
Duration of Progressive Disease (PD)
|
2 months
|
—
|
4 months
|
SECONDARY outcome
Timeframe: up to 3 yearstime from first dose to 30 days post last dose
Outcome measures
| Measure |
Treatment Cohort 1 AA & GBM
n=5 Participants
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 2 Anaplastic PXAs
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
Treatment Cohort 3 Other Tumors
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle
Research Bloods
Encorafenib: 450mg QD 28 day cycle
Binimetinib: 45mg BID 28 day cycle
Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
|
|---|---|---|---|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Dysphasia
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
alanine aminotransferase increased
|
60 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
anemia
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
blurred vision
|
40 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
CK serum
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
CPK increased
|
60 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
dysuria
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
fatigue
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
fever
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
floaters
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
insomnia
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
musculoskeletal, connective tissue disorder
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
myalgia
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
pain
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
right ciliorecinal artery occlusion
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
rash acneiform
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
retinopathy
|
40 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
urinary tract infection
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
vision decreased
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
weight gain
|
20 percentage of patients
|
—
|
—
|
|
Number of Participants With Adverse Events as Defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
ASPARTATE AMINOTRANSFERASE INCREASED
|
40 percentage of patients
|
—
|
—
|
Adverse Events
Patients Treated With Encorafenib or Binimetinib in All Cohorts
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Patients Treated With Encorafenib or Binimetinib in All Cohorts
n=5 participants at risk
Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both.
Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors
|
|---|---|
|
Investigations
CPK Increase
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Eye disorders
eye disorder other
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Patients Treated With Encorafenib or Binimetinib in All Cohorts
n=5 participants at risk
Toxicities with possible, or probable, or definite attribution to encorafenib or binimetinib, or both.
Treatment Cohort 1 AA \& GBM Treatment Cohort 2 anaplastic PXAs Treatment Cohort 3 Other Tumors
|
|---|---|
|
Nervous system disorders
DYSPHASIA
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Eye disorders
BLURRED VISION
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Investigations
CK SERUM
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
CPK INCREASED
|
60.0%
3/5 • Number of events 3 • Up to 3 years
|
|
Renal and urinary disorders
DYSURIA
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
FATIGUE
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Eye disorders
FLOATERS
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
INSOMNIA
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CONNECTIVE TISSUE DISORDER
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
PAIN
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Eye disorders
RETINOPATHY
|
40.0%
2/5 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Eye disorders
VISION DECREASED
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
Investigations
WEIGHT GAIN
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
|
General disorders
FEVER
|
20.0%
1/5 • Number of events 1 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place