Trial Outcomes & Findings for Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma (NCT NCT02844439)

Last Updated: 2021-09-22

Results Overview

Proportion (%) of subjects who did not have progressive disease after treatment with tesevatinib at 6 months (PFS-6) after baseline

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

6 months

Results posted on

2021-09-22

Participant Flow

Subjects at least 18 years of age with recurrent glioblastoma and no concurrent therapeutic intervention including prior exposure to EGFR inhibitors, VEGF, carmustine wafer, or intracerebral agent

A total of 40 subjects with recurrent glioblastoma were enrolled. Tumor samples were evaluated for the presence or absence of EGFR gene-amplification, designated Sub-population A, and/or the EGFR variant III mutation (EGFRvIII\^pos), designated Sub-population B, or neither EGFR gene-amplification nor EGFRvIII\^pos variant mutation. Note: EGFR = epidermal growth factor receptor; EGFR vIII\^pos = EGFR variant 3 mutation; VEGF = vascular endothelial growth factor

Participant milestones

Participant milestones
Measure	Total Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos glioblastoma
Overall Study STARTED	40
Overall Study Subpopulation A (EGFR Gene Amplified Glioblastoma)	24
Overall Study Subpopulation B (EGFRvIII^Pos Glioblastoma)	11
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos glioblastoma
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2
Overall Study Termination by Sponsor	4
Overall Study Death	28
Overall Study Other	5

Baseline Characteristics

All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total: All Subjects n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified glioblastoma and/or EGFRvIII\^pos variant
Age, Continuous All Subjects	55.9 Years STANDARD_DEVIATION 9.88 • n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Age, Continuous Sub-population A	55.9 Years STANDARD_DEVIATION 8.37 • n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Age, Continuous Sub-population B	56.8 Years STANDARD_DEVIATION 8.49 • n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Age, Customized All Subjects	58.0 Years n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Age, Customized Sub-population A	57.5 Years n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Age, Customized Sub-population B	58.0 Years n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Sex: Female, Male All Subjects · Female	12 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Sex: Female, Male All Subjects · Male	28 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Sex: Female, Male Sub-population A · Female	6 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Sex: Female, Male Sub-population A · Male	18 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Sex: Female, Male Sub-population B · Female	3 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Sex: Female, Male Sub-population B · Male	8 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) All Subjects · Hispanic or Latino	2 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) All Subjects · Not Hispanic or Latino	37 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) All Subjects · Unknown or Not Reported	1 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) Sub-population A (EGFRvIII^pos glioblastoma) · Hispanic or Latino	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) Sub-population A (EGFRvIII^pos glioblastoma) · Not Hispanic or Latino	23 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) Sub-population A (EGFRvIII^pos glioblastoma) · Unknown or Not Reported	1 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) Sub-population B · Hispanic or Latino	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) Sub-population B · Not Hispanic or Latino	11 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Ethnicity (NIH/OMB) Sub-population B · Unknown or Not Reported	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · American Indian or Alaska Native	0 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · Asian	4 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · Native Hawaiian or Other Pacific Islander	0 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · Black or African American	1 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · White	34 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · More than one race	0 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) All Subjects · Unknown or Not Reported	1 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · American Indian or Alaska Native	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · Asian	3 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · Black or African American	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · White	21 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · More than one race	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population A · Unknown or Not Reported	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · American Indian or Alaska Native	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · Asian	2 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · Black or African American	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · White	9 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · More than one race	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Race (NIH/OMB) Sub-population B · Unknown or Not Reported	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Karnofsky Performance Status (KPS) All Subjects · 50 (Score)	0 Participants n=40 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) All Subjects · 60 (Score)	0 Participants n=40 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) All Subjects · 70 (Score)	6 Participants n=40 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) All Subjects · 80 (Score)	15 Participants n=40 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) All Subjects · 90 (Score)	19 Participants n=40 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) All Subjects · 100 (Score)	0 Participants n=40 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population A (EGFRvIII^pos glioblastoma) · 50 (Score)	0 Participants n=24 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population A (EGFRvIII^pos glioblastoma) · 60 (Score)	0 Participants n=24 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population A (EGFRvIII^pos glioblastoma) · 70 (Score)	3 Participants n=24 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population A (EGFRvIII^pos glioblastoma) · 80 (Score)	10 Participants n=24 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population A (EGFRvIII^pos glioblastoma) · 90 (Score)	11 Participants n=24 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population A (EGFRvIII^pos glioblastoma) · 100 (Score)	0 Participants n=24 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population · 50 (Score)	0 Participants n=11 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population · 60 (Score)	0 Participants n=11 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population · 70 (Score)	1 Participants n=11 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population · 80 (Score)	4 Participants n=11 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population · 90 (Score)	6 Participants n=11 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Karnofsky Performance Status (KPS) Sub-population · 100 (Score)	0 Participants n=11 Participants • Karnofsky Performance Score: 50 = requires considerable assistance and frequent medical care; 60 - requires occasional assistance, but is able to care for most of his personal needs; 70 = cares for self but is unable to carry on normal activity or to do active work; 80 = normal activity with effort and some signs or symptoms of disease; 90 - able to carry on normal activity and minor signs of symptoms of disease; 100 = normal no complaints with no evidence of disease
Prior Low Grade Astrocytoma Diagnosis All Subjects · Yes	2 Participants n=40 Participants • Low-grade astrocytoma (diffuse astrocytoma): usually an infiltrating tumor that grows relatively slowly and usually does not have well-defined borders
Prior Low Grade Astrocytoma Diagnosis All Subjects · No	38 Participants n=40 Participants • Low-grade astrocytoma (diffuse astrocytoma): usually an infiltrating tumor that grows relatively slowly and usually does not have well-defined borders
Prior Low Grade Astrocytoma Diagnosis Sub-population A · Yes	0 Participants n=24 Participants • Low-grade astrocytoma (diffuse astrocytoma): usually an infiltrating tumor that grows relatively slowly and usually does not have well-defined borders
Prior Low Grade Astrocytoma Diagnosis Sub-population A · No	24 Participants n=24 Participants • Low-grade astrocytoma (diffuse astrocytoma): usually an infiltrating tumor that grows relatively slowly and usually does not have well-defined borders
Prior Low Grade Astrocytoma Diagnosis Sub-population B · Yes	0 Participants n=11 Participants • Low-grade astrocytoma (diffuse astrocytoma): usually an infiltrating tumor that grows relatively slowly and usually does not have well-defined borders
Prior Low Grade Astrocytoma Diagnosis Sub-population B · No	11 Participants n=11 Participants • Low-grade astrocytoma (diffuse astrocytoma): usually an infiltrating tumor that grows relatively slowly and usually does not have well-defined borders
Months Since First Diagnosis of Glioblastoma: Mean All Subjects	12.59 Months STANDARD_DEVIATION 8.658 • n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since First Diagnosis of Glioblastoma: Mean Sub-population A	13.50 Months STANDARD_DEVIATION 10.032 • n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since First Diagnosis of Glioblastoma: Mean Sub-population B	13.15 Months STANDARD_DEVIATION 9.010 • n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since First Diagnosis of Glioblastoma: Median All Subjects	9.95 Months n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since First Diagnosis of Glioblastoma: Median Sub-population A	8.50 Months n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since First Diagnosis of Glioblastoma: Median Sub-population B	8.50 Months n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since Recurrent Diagnosis of Glioblastoma: Mean All Subjects	1.34 Months STANDARD_DEVIATION 2.123 • n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since Recurrent Diagnosis of Glioblastoma: Mean Sub-population A	1.58 Months STANDARD_DEVIATION 2.707 • n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since Recurrent Diagnosis of Glioblastoma: Mean Sub-population B	1.14 Months STANDARD_DEVIATION 0.916 • n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since Recurrent Diagnosis of Glioblastoma: Median All Subjects	0.90 Months n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since Recurrent Diagnosis of Glioblastoma: Median Sub-population A (EGFRvIII^pos glioblastoma)	0.80 Months n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Months Since Recurrent Diagnosis of Glioblastoma: Median Sub-population B	0.80 Months n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Number of Prior Systemic Therapy Regimens All Subjects · 1 Regimen	21 Participants n=40 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens All Subjects · 2 Regimens	16 Participants n=40 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens All Subjects · > 2 Regimens	2 Participants n=40 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens All Subjects · No Prior Systemic Therapy	1 Participants n=40 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population A · 1 Regimen	13 Participants n=24 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population A · 2 Regimens	11 Participants n=24 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population A · > 2 Regimens	0 Participants n=24 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population A · No Prior Systemic Therapy	0 Participants n=24 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population B · 1 Regimen	5 Participants n=11 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population B · 2 Regimens	6 Participants n=11 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population B · > 2 Regimens	0 Participants n=11 Participants • Data were not available for all subjects
Number of Prior Systemic Therapy Regimens Sub-population B · No Prior Systemic Therapy	0 Participants n=11 Participants • Data were not available for all subjects
Prior Surgery All Subjects · Yes	39 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery All Subjects · No	0 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery All Subjects · Unknown	1 Participants n=40 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery Sub-population A · Yes	24 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery Sub-population A · No	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery Sub-population A · Unknown	0 Participants n=24 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery Sub-population B · Yes	11 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery Sub-population B · No	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Surgery Sub-population B · Unknown	0 Participants n=11 Participants • All Subjects: With or without EGFR gene-amplified and/or EGFRvIII\^pos variant. Sub-population A: EGFR gene-amplified. Sub-population B: EGFRvIII\^pos variant (Subset of Sub-population A).
Prior Radiotherapy--Site Irradiated All Subjects · Brain	29 Participants n=40 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Prior Radiotherapy--Site Irradiated All Subjects · Other	11 Participants n=40 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Prior Radiotherapy--Site Irradiated Sub-population A · Brain	17 Participants n=24 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Prior Radiotherapy--Site Irradiated Sub-population A · Other	7 Participants n=24 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Prior Radiotherapy--Site Irradiated Sub-population · Brain	7 Participants n=11 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Prior Radiotherapy--Site Irradiated Sub-population · Other	4 Participants n=11 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Best Overall Response All Subjects · CR	0 Participants n=40 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response All Subjects · PR	0 Participants n=40 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response All Subjects · SD	21 Participants n=40 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response All Subjects · PD	9 Participants n=40 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response All Subjects · Unknown	10 Participants n=40 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population A · CR	0 Participants n=24 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population A · PR	0 Participants n=24 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population A · SD	12 Participants n=24 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population A · PD	6 Participants n=24 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population A · Unknown	6 Participants n=24 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population B · CR	0 Participants n=11 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population B · PR	0 Participants n=11 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population B · SD	5 Participants n=11 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population B · PD	1 Participants n=11 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Best Overall Response Sub-population B · Unknown	5 Participants n=11 Participants • Response Criteria in Solid Tumors (RECIST): CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease;
Reason Therapy Ended All Subjects · Treatment Completed	11 Participants n=39 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended All Subjects · Progressive Disease	24 Participants n=39 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended All Subjects · Study Drug Toxicity	1 Participants n=39 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended All Subjects · Other	3 Participants n=39 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population A · Treatment Completed	8 Participants n=24 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population A · Progressive Disease	13 Participants n=24 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population A · Study Drug Toxicity	1 Participants n=24 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population A · Other	2 Participants n=24 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population B · Treatment Completed	5 Participants n=11 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population B · Progressive Disease	4 Participants n=11 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population B · Study Drug Toxicity	1 Participants n=11 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Reason Therapy Ended Sub-population B · Other	1 Participants n=11 Participants • Analysis is for Sub-populations A and B, and for total which includes subjects in both Sub-populations A and B, and neither sub-population.
Corticosteroid Used at Baseline All Subjects · None	3 Participants n=40 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline All Subjects · Dose increased	0 Participants n=40 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline All Subjects · Dose decreased	0 Participants n=40 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline All Subjects · Dose stable	1 Participants n=40 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline All Subjects · Unknown	36 Participants n=40 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population A · None	2 Participants n=24 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population A · Dose increased	0 Participants n=24 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population A · Dose decreased	0 Participants n=24 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population A · Dose stable	1 Participants n=24 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population A · Unknown	21 Participants n=24 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population B · None	0 Participants n=11 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population B · Dose increased	0 Participants n=11 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population B · Dose decreased	0 Participants n=11 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population B · Dose stable	1 Participants n=11 Participants • Data only available for 4 subjects
Corticosteroid Used at Baseline Sub-population B · Unknown	10 Participants n=11 Participants • Data only available for 4 subjects

PRIMARY outcome

Timeframe: 6 months

Proportion (%) of subjects who did not have progressive disease after treatment with tesevatinib at 6 months (PFS-6) after baseline

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6)	22.5 Percentage (%) of subjects Interval 10.8 to 38.5	25.0 Percentage (%) of subjects Interval 9.8 to 46.7	18.2 Percentage (%) of subjects Interval 2.3 to 51.8

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or clinician decision to discontinue, death, or up to 3 years, whichever occurred first

Median duration (months) of subjects who were progression-free of disease from baseline

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Efficacy: Median PFS	2.3 Months Interval 1.08 to 2.96	1.7 Months Interval 0.95 to 2.96	1.0 Months Interval 0.92 to 4.93

SECONDARY outcome

Timeframe: 9 months

Median proportion (%) of subjects who survived 9 months after baseline

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Efficacy: Median Overall Survival Rate at 9 Months (OS-9)	42.5 Percentage (%) of subjects Interval 27.0 to 59.1	37.5 Percentage (%) of subjects Interval 18.8 to 59.4	27.3 Percentage (%) of subjects Interval 6.0 to 61.0

SECONDARY outcome

Timeframe: Until unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first

Median duration (months) subjects survived from baseline until death

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Efficacy: Median OS	8.4 Months Interval 7.36 to 12.29	7.8 Months Interval 6.64 to 15.67	7.6 Months Interval 4.93 to 16.62

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first

Population: Note: NA = data not available; NE = not evaluable

Best overall response that subjects had to treatment with tesevatinib: complete response (CR), partial response (PR), stable disease (SD), or non-response/progressive disease (PD)

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Efficacy: Best Overall Response NA	3 Participants	2 Participants	1 Participants
Efficacy: Best Overall Response CR	0 Participants	0 Participants	0 Participants
Efficacy: Best Overall Response PR	1 Participants	1 Participants	1 Participants
Efficacy: Best Overall Response SD	22 Participants	10 Participants	2 Participants
Efficacy: Best Overall Response PD	13 Participants	10 Participants	6 Participants
Efficacy: Best Overall Response NE	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or 3 years, whichever occurred first

Proportion (%) of subjects who had either a complete response (CR) or a partial response (PR) to treatment with tesevatinib

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Efficacy: Objective Response Rate (ORR)	2.5 Percentage (%) of participants Interval 0.0 to 13.0	4.2 Percentage (%) of participants Interval 0.0 to 21.0	9.1 Percentage (%) of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first

Mean total amount of tesevatinib (mg) subjects received during the study

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Exposure to Tesevatinib: Overall Mean	26670.0 mg (tesevatinib) Standard Deviation 44533.38	21752.1 mg (tesevatinib) Standard Deviation 34748.96	11481.8 mg (tesevatinib) Standard Deviation 7024.22

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first

Median amount of tesevatinib (mg) subjects received during the study

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Exposure to Tesevatinib: Overall Median	11850.0 mg (tesevatinib) Interval 3900.0 to 210850.0	10350.0 mg (tesevatinib) Interval 4500.0 to 179150.0	8700.0 mg (tesevatinib) Interval 4500.0 to 25500.0

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first.

Mean number of 28-day cycles of treatment with tesevatinib subjects received during the study

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Exposure to Tesevatinib: Mean Number of Cycles	3.8 Number of cycles Standard Deviation 6.72	3.3 Number of cycles Standard Deviation 6.26	1.8 Number of cycles Standard Deviation 1.54

SECONDARY outcome

Timeframe: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first

Median number of 28-day cycles of treatment with tesevatinib subjects received during the study

Outcome measures

Outcome measures
Measure	Total n=40 Participants Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant	Sub-population A n=24 Participants Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 Participants Subjects with EGFR gene-amplified and EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Exposure to Tesevatinib: Median Number of Cycles	2.0 Number of cycles Interval 1.0 to 32.0	1.5 Number of cycles Interval 1.0 to 32.0	1.0 Number of cycles Interval 1.0 to 6.0

Adverse Events

Total

Serious events: 12 serious events

Other events: 40 other events

Deaths: 28 deaths

Sub-population A

Serious events: 7 serious events

Other events: 24 other events

Deaths: 19 deaths

Sub-population B

Serious events: 2 serious events

Other events: 11 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Miranda Ross

Kadmon Corporation

Phone: 724-778-6170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Total n=40 participants at risk Subjects with recurrent glioblastoma who had or did not have EGFR gene-amplified and/or EGFRvIII\^pos variant glioblastoma. Includes 24 subjects who had EGFR gene-amplified (Sub-population A, 11 subjects who had EGFRvIII\^pos and EGFR gene-amplified (Sub-population B which is a subset of Sub-population A) and 16 subjects who were in neither sub-population	Sub-population A n=24 participants at risk Subjects with EGFR gene-amplified glioblastoma	Sub-population B n=11 participants at risk Subjects with EGFRvIII\^pos variant glioblastoma (Subset of Sub-population A)
Nervous system disorders Hemiparesis	5.0% 2/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	8.3% 2/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Nervous system disorders Brain edema	5.0% 2/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Nervous system disorders Cerebrovascular accident	5.0% 2/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Nervous system disorders Aphasia	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Nervous system disorders Cerebral hemorrhage	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	9.1% 1/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Nervous system disorders Facial paralysis	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Nervous system disorders Seizure	0.00% 0/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	8.3% 2/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	9.1% 1/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Psychiatric disorders Mental status changes	5.0% 2/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Psychiatric disorders Confusional state	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Infections and infestations Abdominal abscess	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Infections and infestations Appendicitis	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Infections and infestations Pelvic abscess	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Infections and infestations Wound infection	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Gastrointestinal disorders Pancreatitis	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	9.1% 1/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Gastrointestinal disorders Pancreatitis acute	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	9.1% 1/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Injury, poisoning and procedural complications Wound dehiscene	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Musculoskeletal and connective tissue disorders Muscular weakness	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	4.2% 1/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.
Renal and urinary disorders Acute kidney injury	2.5% 1/40 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/24 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.	0.00% 0/11 • Subjects were followed for treatment-emergent adverse events and other safety assessments from screening through 30-day follow-up.