Trial Outcomes & Findings for TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma (NCT NCT03032484)
NCT ID: NCT03032484
Last Updated: 2023-06-15
Results Overview
Survival of participants at 6 months after the start of treatment without their condition becoming any worse. Brain magnetic resonance imaging (MRI) was performed after every even cycle (e.g., C2, C4) during treatment, with tumor response assessed by the investigator for complete response (CR), partial response (PR) and PD according to the Response Assessment in Neuro-oncology (RANO) criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-15
Participant Flow
A cycle 1 randomization to either TVB-2640 plus bevacizumab or bevacizumab monotherapy was conducted in this trial. This randomization was performed for biomarker analysis only and was not intended to be comparative for either safety or efficacy, as it would be unexpected to observe a difference in survival after only one cycle of a study drug.
Participant milestones
| Measure |
Bevacizumab and TVB-2640
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
Bevacizumab
Bevacizumab alone every 2 weeks, on days 1 and 15 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
|
|---|---|---|
|
Overall Study Cycle 1 (C1)
STARTED
|
13
|
12
|
|
Overall Study Cycle 1 (C1)
COMPLETED
|
12
|
12
|
|
Overall Study Cycle 1 (C1)
NOT COMPLETED
|
1
|
0
|
|
Start of Second Cycle (C2)
STARTED
|
24
|
0
|
|
Start of Second Cycle (C2)
COMPLETED
|
23
|
0
|
|
Start of Second Cycle (C2)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Bevacizumab and TVB-2640
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
Bevacizumab
Bevacizumab alone every 2 weeks, on days 1 and 15 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
|
|---|---|---|
|
Overall Study Cycle 1 (C1)
Withdrawal by Subject
|
1
|
0
|
|
Start of Second Cycle (C2)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma
Baseline characteristics by cohort
| Measure |
Bevacizumab and TVB-2640
n=25 Participants
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsSurvival of participants at 6 months after the start of treatment without their condition becoming any worse. Brain magnetic resonance imaging (MRI) was performed after every even cycle (e.g., C2, C4) during treatment, with tumor response assessed by the investigator for complete response (CR), partial response (PR) and PD according to the Response Assessment in Neuro-oncology (RANO) criteria.
Outcome measures
| Measure |
Bevacizumab and TVB-2640
n=23 Participants
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
|---|---|
|
Progression Free Survival at 6 Months (PFS6)
|
47 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 28-day cyclesPopulation: Subject who received TVB-2640 and Bevacizumab or Bevacizumab alone
Number of adverse of any nature are reported as well as the number of adverse events that were classed as grade 3-5 on the NCI - Common Toxicity Criteria for Adverse Events
Outcome measures
| Measure |
Bevacizumab and TVB-2640
n=23 Participants
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
|---|---|
|
Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03)
Number of adverse events any grade
|
183 number of events
|
|
Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03)
Adverse events grade 3-5
|
27 number of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 2: approximately 56 daysPopulation: Data were not evaluable for this measure, since MRI resolution was inadequate
The MRI was performed during cycle 2. This procedure was intended to be outsourced, and MRIs performed locally produced inadequate resolution, so no data analysis was obtained from this measure.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab and TVB-2640
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab and TVB-2640
n=23 participants at risk
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
|---|---|
|
Nervous system disorders
Aphasia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Infections and infestations
Wound infection
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
Other adverse events
| Measure |
Bevacizumab and TVB-2640
n=23 participants at risk
Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
Bevacizumab: Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
TVB-2640: TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Palmar plantar erythrodysesthesia syndrome
|
78.3%
18/23 • Number of events 41 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
65.2%
15/23 • Number of events 22 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Cardiac disorders
Hypertension
|
56.5%
13/23 • Number of events 21 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Eye disorders
Dry Eye
|
52.2%
12/23 • Number of events 13 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
General disorders
Fatigue
|
30.4%
7/23 • Number of events 9 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
21.7%
5/23 • Number of events 5 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Skin and subcutaneous tissue disorders
alopecia
|
21.7%
5/23 • Number of events 5 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
21.7%
5/23 • Number of events 6 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Hepatobiliary disorders
Elevated ALT/AST
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Nervous system disorders
Depression
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Gastrointestinal disorders
Dysphasia
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
General disorders
Headache
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Musculoskeletal and connective tissue disorders
Parestheisa
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.7%
2/23 • Number of events 4 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Nervous system disorders
Cognitive Disturbance
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Eye disorders
Conjunctivitis
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Gastrointestinal disorders
Dry Mouth
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Blood and lymphatic system disorders
Limb edema
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Renal and urinary disorders
Hypokalemia
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Gastrointestinal disorders
Anorexia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Nervous system disorders
Aphasia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
|
Nervous system disorders
Confusion
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
|
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Renal and urinary disorders
Increased Creatinine
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from study enrollment for up to six cycles (28 days each) or until there is evidence of significant treatment related toxicity or progressive disease. Subject were assessed for adverse events which occurred after the start of treatment until 30 days after study drug discontinuation or subsequent cancer therapy was initiated. Adverse events were collected over a 1.5 year period.
Bevacizumab during cycle 1 and Bevacizumab and TVB-2640 were combined as pre-specified in the study protocol
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Additional Information
Andrew Brenner, MD
University of Texas Health San Antonio
Phone: 210-562-4090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place