Trial Outcomes & Findings for A Pilot Study of Bevacizumab for Neoplastic Meningitis (NCT NCT00924820)
NCT ID: NCT00924820
Last Updated: 2020-12-31
Results Overview
CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response, e.g. participants with continued positive CSF cytology or flow cytometry.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1 year (54 weeks) of treatment
Results posted on
2020-12-31
Participant Flow
Recruitment Period: June 15, 2009 to February 28, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Bevacizumab
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Bevacizumab
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Ineligible, Screen Failure
|
5
|
Baseline Characteristics
A Pilot Study of Bevacizumab for Neoplastic Meningitis
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=20 Participants
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year (54 weeks) of treatmentPopulation: Of the 20 registered, 5 were screening failures therefore are not included in the analysis.
CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response, e.g. participants with continued positive CSF cytology or flow cytometry.
Outcome measures
| Measure |
Bevacizumab
n=15 Participants
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells
|
93 percentage of participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Of the 20 registered, 5 were screening failures therefore are not included in the analysis.
Time to Progression defined as time to disease progression measured from date of enrollment, confirmation of disease progression via laboratory testing; Time to neurological progression (TTNP) reflects worsening clinical signs/symptoms or development of new clinical signs/symptoms which investigator feels can be attributed to leptomeningeal disease progression and are severe enough to warrant a change in therapy.
Outcome measures
| Measure |
Bevacizumab
n=15 Participants
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP)
TTP
|
3 Weeks
Interval 0.0 to 6.0
|
|
Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP)
TTNP
|
3 Weeks
Interval 0.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year (54 weeks) of treatmentPopulation: Of the 20 registered, 5 were screening failures therefore are not included in the analysis.
Neoplastic meningitis is considered an unmeasurable metastatic site by Response Evaluation Criteria in Solid Tumors (RECIST), and as such no standardized methodologies are routinely used; therefore response assessed from cerebrospinal fluid (CSF) obtained via lumbar puncture (and from ventricular reservoir if present) and analyzed for malignant cells along with reference recording of magnetic resonance imaging (MRI) of areas of enhancement over time; however, MRI alone in LMD/NM is considered non-evaluable by RECIST criteria. Those participants with only MRI criteria for enrollment, but who later develop CSF positivity after enrollment were declared "progressors" based on the CSF criteria.
Outcome measures
| Measure |
Bevacizumab
n=15 Participants
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Participant Response: Cerebrospinal Fluid (CSF) Examination
No Change/Stable Disease (SD)
|
6 participants
|
|
Participant Response: Cerebrospinal Fluid (CSF) Examination
Progressive Disease (PD)
|
8 participants
|
|
Participant Response: Cerebrospinal Fluid (CSF) Examination
Complete Remission (CR)
|
1 participants
|
Adverse Events
Bevacizumab
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=15 participants at risk
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Gastrointestinal disorders
Pain, Gastrointestinal Abdomen
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Wound Complications/Infection
|
6.7%
1/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Fatique
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Death
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Seizure
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Pain, Musculoskeletal
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Confusion
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
Other adverse events
| Measure |
Bevacizumab
n=15 participants at risk
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
53.3%
8/15 • Number of events 9 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
5/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Alkaline phosphatase increased
|
26.7%
4/15 • Number of events 6 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.7%
7/15 • Number of events 7 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
9/15 • Number of events 11 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Psychiatric disorders
Anxiety
|
40.0%
6/15 • Number of events 6 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
6/15 • Number of events 10 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Ataxia
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
60.0%
9/15 • Number of events 10 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Bilirubin increased
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
20.0%
3/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
80.0%
12/15 • Number of events 33 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
13.3%
2/15 • Number of events 6 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Bruising
|
13.3%
2/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Infections and infestations
Catheter related infection
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Cardiac disorders
Chest pain
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Cognitive disturbance
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Psychiatric disorders
Confusion
|
20.0%
3/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Constipation
|
60.0%
9/15 • Number of events 13 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
4/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Creatinine increased
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Depressed level of consciousness
|
33.3%
5/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Psychiatric disorders
Depression
|
40.0%
6/15 • Number of events 7 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Number of events 6 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Eye disorders
Diplopia
|
33.3%
5/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Eye disorders
Dry eye syndrome
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
3/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
5/15 • Number of events 7 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Edema limbs
|
33.3%
5/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Facial muscle weakness
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Facial nerve disorder
|
6.7%
1/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Fatigue
|
100.0%
15/15 • Number of events 23 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Fecal incontinence
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Gait abnormal
|
86.7%
13/15 • Number of events 17 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Gastrointestinal (Other)
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Headache
|
53.3%
8/15 • Number of events 13 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Ear and labyrinth disorders
Hearing loss
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Hemoglobin decreased
|
73.3%
11/15 • Number of events 34 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Vascular disorders
Hypertension
|
20.0%
3/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Infections and infestations
Infection
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Psychiatric disorders
Insomnia
|
66.7%
10/15 • Number of events 10 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Eye disorders
Keratitis
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Blood and lymphatic system disorders
Leukopenia
|
60.0%
9/15 • Number of events 16 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Blood and lymphatic system disorders
Lymphatics (Other)
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
73.3%
11/15 • Number of events 37 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Memory impairment
|
26.7%
4/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory (Other)
|
100.0%
15/15 • Number of events 55 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Psychiatric disorders
Mini mental status examination abnormal
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis oral
|
13.3%
2/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
46.7%
7/15 • Number of events 10 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
20.0%
3/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
46.7%
7/15 • Number of events 10 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
6.7%
1/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (Other)
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
12/15 • Number of events 21 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Neurology (Other)
|
60.0%
9/15 • Number of events 12 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
20.0%
3/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Eye disorders
Ocular/Visual (Other)
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Eye disorders
Optic nerve disorder
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Pain
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
General disorders
Pain (Other)
|
26.7%
4/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
53.3%
8/15 • Number of events 13 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
46.7%
7/15 • Number of events 9 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Platelet count decreased
|
26.7%
4/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (Other)
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
13.3%
2/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Seizure
|
20.0%
3/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
40.0%
6/15 • Number of events 6 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum cacium decreased
|
33.3%
5/15 • Number of events 13 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum cholesterol increased
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum glucose decrease
|
13.3%
2/15 • Number of events 5 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
40.0%
6/15 • Number of events 10 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
13.3%
2/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.7%
1/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
53.3%
8/15 • Number of events 18 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
46.7%
7/15 • Number of events 14 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Speech disorder
|
33.3%
5/15 • Number of events 6 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Syncope vasovagal
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Taste alteration
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Nervous system disorders
Tremor
|
13.3%
2/15 • Number of events 2 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
3/15 • Number of events 3 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
3/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Cardiac disorders
Ventricular tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Eye disorders
Vision blurred
|
26.7%
4/15 • Number of events 4 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
10/15 • Number of events 14 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Weight gain
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Investigations
Weight loss
|
26.7%
4/15 • Number of events 7 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.7%
1/15 • Number of events 1 • Adverse event data for study collected for up to 54 weeks (about 1 year), up to 30 days after the date of the last drug administration.
Of the twenty participants, five were not treated and therefore are not included in the adverse event reporting.
|
Additional Information
John F de Groot, Professor, Neuro-Oncology
The University of Texas (UT) MD Anderson Cancer Center
Phone: (713) 745-3072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place