Trial Outcomes & Findings for Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma (NCT NCT01582152)
NCT ID: NCT01582152
Last Updated: 2019-06-05
Results Overview
Progression free survival (PFS) measured from time of registration until date of progression or death (whichever is earlier) (event time) or last date participant was known to be alive without progression (censoring time).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
PFS will be evaluated as a continuous variable, up to one year
Results posted on
2019-06-05
Participant Flow
Recruitment Period: July 24, 2012 to June 02, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Study was terminated early without advancing to the second portion (Phase II).
Participant milestones
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
TPI287 160 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
TPI287 140 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
TPI287 160 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
TPI287 140 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
|
|---|---|---|
|
Overall Study
Disease Progression
|
4
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
n=6 Participants
TPI287 160 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
n=6 Participants
TPI287 140 mg/m2 given intravenous (IV) on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg IV on Day 1 every 2 weeks of a 42 Day cycle.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
n=5 Participants
|
52 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PFS will be evaluated as a continuous variable, up to one yearProgression free survival (PFS) measured from time of registration until date of progression or death (whichever is earlier) (event time) or last date participant was known to be alive without progression (censoring time).
Outcome measures
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
n=6 Participants
TPI287 160 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
n=6 Participants
TPI287 140 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
12.5 weeks
Interval 6.0 to 37.0
|
9.5 weeks
Interval 7.0 to 44.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Two participants, one in each arm was not evaluable for response.
ORR is number participants who experience complete response (CR) or partial response (PR) analyzed for completion of at least one cycle in all treatment arms, including exploratory treatment arm. CR requires: 1) complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; 2) no new lesions; 3) stable or improved non-enhancing (T2/FLAIR) lesions; 4) off corticosteroids (or on physiologic replacement doses only); 5) stable or improved clinically. Partial response (PR) requires: 1) \>50% decrease compared with baseline in sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; 2) No progression of non-measurable disease; 3) No new lesions; 4) Stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; 5) corticosteroid dose at time of scan should be \< dose at baseline scan; 6) Improved or stable clinically
Outcome measures
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
n=5 Participants
TPI287 160 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
n=5 Participants
TPI287 140 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
40 percentage of participants
|
0 percentage of participants
|
Adverse Events
TPI 287 160 mg/m2 + Bevacizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
TPI 287 140 mg/m2 + Bevacizumab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
n=6 participants at risk
TPI287 160 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
n=6 participants at risk
TPI287 140 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
|---|---|---|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Cardiac disorders
Chest Pain
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Hydrocephalus
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
Other adverse events
| Measure |
TPI 287 160 mg/m2 + Bevacizumab
n=6 participants at risk
TPI287 160 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
TPI 287 140 mg/m2 + Bevacizumab
n=6 participants at risk
TPI287 140 mg/m2 IV on Day 1 every three weeks + Bevacizumab 10 mg/kg IV on Day 1 every 2 weeks of 42 Day cycle.
|
|---|---|---|
|
Investigations
Elevated lactate dehydrogenase (LD) (Other)
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Eye disorders
Eye Disorders - (Other)
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Eye disorders
Eye Infection
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Facial Muscle Weakness
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Fatigue
|
100.0%
6/6 • Number of events 13 • Adverse event data collected through 42 day treatment period.
|
100.0%
6/6 • Number of events 11 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Gait Disturbance
|
50.0%
3/6 • Number of events 6 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
66.7%
4/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
100.0%
6/6 • Number of events 6 • Adverse event data collected through 42 day treatment period.
|
|
Psychiatric disorders
Hallucinations
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 8 • Adverse event data collected through 42 day treatment period.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Hemoglobin Increased
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Hydrocephalus
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
83.3%
5/6 • Number of events 10 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 7 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Hypersomnia
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 8 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Cardiac disorders
Atrial Fibrillation
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Bicarbonate Serum-Low
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Bilirubin Changes
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Bilirubin Increase
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Blood Bilirubin Increased
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Eye disorders
Blurred Vision
|
66.7%
4/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Blood urea nitrogen (BUN) Increase
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Cardiac disorders
Chest Wall Pain
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Cholesterol High
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Cognitive Disturbance
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Psychiatric disorders
Confusion
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
66.7%
4/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
creatine phosphokinase (CPK) Increased
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Creatinine Increased
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Endocrine disorders
Cushingoid
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
66.7%
4/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 8 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders - (Other)
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Ear and labyrinth disorders
Ear Pain
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Edema Face
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Edema Limbs
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Alkaline Phosphatase Increased
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Immune system disorders
Allergic Rhinitis
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
5/6 • Number of events 13 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 10 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 6 • Adverse event data collected through 42 day treatment period.
|
|
Psychiatric disorders
Anxiety
|
83.3%
5/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Irritability
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
2/6 • Number of events 6 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 14 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Lymphocyte Count Decreased
|
33.3%
2/6 • Number of events 11 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 27 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Lymphocyte Count Increased
|
33.3%
2/6 • Number of events 7 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Memory Impairment
|
83.3%
5/6 • Number of events 9 • Adverse event data collected through 42 day treatment period.
|
66.7%
4/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - (Other)
|
83.3%
5/6 • Number of events 9 • Adverse event data collected through 42 day treatment period.
|
100.0%
6/6 • Number of events 16 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Mucositis Oral
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Left-Sided
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Right-Sided
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Neutrophil Count Decreased
|
16.7%
1/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Eye disorders
Optic Nerve Disorder
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Oral Pain
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
66.7%
4/6 • Number of events 7 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Cardiac disorders
Palpitations
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Periodontal Disease
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
83.3%
5/6 • Number of events 8 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Platelet Count Decreased
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
16.7%
1/6 • Number of events 4 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 5 • Adverse event data collected through 42 day treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Seizure
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
83.3%
5/6 • Number of events 6 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Skin Infection
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
50.0%
3/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Tooth Infection
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Renal and urinary disorders
Urinary Frequency
|
33.3%
2/6 • Number of events 3 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Renal and urinary disorders
Urinary Incontinence
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
33.3%
2/6 • Number of events 2 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Weight Gain
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Investigations
Weight Loss
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
0.00%
0/6 • Adverse event data collected through 42 day treatment period.
|
|
Infections and infestations
Wound Infection
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
16.7%
1/6 • Number of events 1 • Adverse event data collected through 42 day treatment period.
|
Additional Information
Dr. Alfred Yung, Clinical Professor, Neuro-Oncology
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place