Trial Outcomes & Findings for Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG) (NCT NCT00671970)
NCT ID: NCT00671970
Last Updated: 2013-05-13
Results Overview
The proportion of patients alive and progression free at 6 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
6 months
Results posted on
2013-05-13
Participant Flow
Open for recruitment from February 2007 to May 2008. Subjects recruited in the Preston Robert Tisch Brian Tumor Center at Duke University Medical Center (DUMC).
Participant milestones
| Measure |
WHO Grade III
WHO Grade III Malignant Glioma
Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs \& 500 mg/day for pts on EIAEDs.
|
WHO Grade IV
WHO Grade IV Malignant Glioma
Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs \& 500 mg/day for pts on EIAEDs.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
25
|
|
Overall Study
COMPLETED
|
32
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG)
Baseline characteristics by cohort
| Measure |
Who Grade III
n=32 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=25 Participants
WHO Grade IV Malignant Glioma
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
49.98 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe proportion of patients alive and progression free at 6 months
Outcome measures
| Measure |
Who Grade III
n=32 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=25 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
6 Month Progression-free Survival
|
.438 proportion of participants
Interval 0.265 to 0.598
|
.292 proportion of participants
Interval 0.13 to 0.476
|
SECONDARY outcome
Timeframe: Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participantsThe number of participants with complete or partial response as determined by the following criteria: * Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. * Partial response (PR): Greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.
Outcome measures
| Measure |
Who Grade III
n=32 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=25 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Radiographic Response
Complete
|
1 participants
|
1 participants
|
|
Radiographic Response
Partial
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Day 1 and 42 of Dosing ErlotinibPopulation: 22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib
Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Maximum Concentration (ng/mL) (Cmax) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib
Outcome measures
| Measure |
Who Grade III
n=22 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Pharmacokinetics of Erlotinib: Cmax
Day1 Cmax{ng/ml}200mg n=12
|
794 ng/ml
Interval 524.0 to 2200.0
|
—
|
|
Pharmacokinetics of Erlotinib: Cmax
Day1 Cmax{ng/ml}500mg n=10
|
1323 ng/ml
Interval 317.0 to 2990.0
|
—
|
|
Pharmacokinetics of Erlotinib: Cmax
Day42 Cmax{ng/ml}200mg n=9
|
1320 ng/ml
Interval 525.0 to 2940.0
|
—
|
|
Pharmacokinetics of Erlotinib: Cmax
Day42 Cmax{ng/ml}500mg n=9
|
1400 ng/ml
Interval 716.0 to 3955.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 42 of Dosing ErlotinibPopulation: 22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib
Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Area under the Curve (ng/mL.h) (AUC) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib
Outcome measures
| Measure |
Who Grade III
n=22 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Pharmacokinetics of Erlotinib: AUC
Day42 AUC 0-24{ng/ml.h}500mg n=9
|
21421 ng/ml.h
Interval 11680.0 to 55960.0
|
—
|
|
Pharmacokinetics of Erlotinib: AUC
Day1 AUC 0-24{ng/ml.h} 200mg n=12
|
11072 ng/ml.h
Interval 7850.0 to 30029.0
|
—
|
|
Pharmacokinetics of Erlotinib: AUC
Day1 AUC 0-24{ng/ml.h} 500mg n=10
|
15611 ng/ml.h
Interval 5295.0 to 40110.0
|
—
|
|
Pharmacokinetics of Erlotinib: AUC
Day42 AUC 0-24{ng/ml.h}200mg n=9
|
26072 ng/ml.h
Interval 8308.0 to 42878.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis
Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.
Outcome measures
| Measure |
Who Grade III
n=20 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=1 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR)
|
7 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit.
Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.
Outcome measures
| Measure |
Who Grade III
n=5 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=17 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - EGFR vIII
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis.
Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.
Outcome measures
| Measure |
Who Grade III
n=2 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=19 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN)
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Four tumors had an insufficient measurement for analysis.
Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.
Outcome measures
| Measure |
Who Grade III
n=16 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=2 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT)
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Six tumors had an insufficient measurement for analysis.
Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.
Outcome measures
| Measure |
Who Grade III
n=12 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=4 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK)
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearArchival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC expression score is the product of the percentage of cancer cells positive for VEGF multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.
Outcome measures
| Measure |
Who Grade III
n=8 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=14 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF)
|
40 IHC Expression Score
Interval 4.0 to 120.0
|
60 IHC Expression Score
Interval 20.0 to 160.0
|
SECONDARY outcome
Timeframe: 1 yearArchival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC score is the product of the percentage of cancer cells positive for VEGFR-2 multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.
Outcome measures
| Measure |
Who Grade III
n=8 Participants
Who Grade III Malignant Glioma
|
WHO Grade IV
n=14 Participants
WHO Grade IV Malignant Glioma
|
|---|---|---|
|
Association of Biomarkers and One-year Survival - VEGFR-2
|
50 IHC Expression Score
Interval 20.0 to 100.0
|
120 IHC Expression Score
Interval 40.0 to 160.0
|
Adverse Events
All Patients
Serious events: 20 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=57 participants at risk
All Patients
|
|---|---|
|
Gastrointestinal disorders
Colonic ulcer
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Death NOS
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Gait disturbance
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Device related infection
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Meningitis
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Skin infection
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Wound dihiscence
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Ischemia cerebrovascular
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders-Other, specify: Visual Hallucinations
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Pyramidal tract syndrome
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Seizure
|
8.8%
5/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Tremor
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Personality change
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Psychosis
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
1/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.5%
2/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Thromboembolic event
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
All Patients
n=57 participants at risk
All Patients
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.5%
10/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Blurred vision
|
24.6%
14/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
22.8%
13/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
49.1%
28/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
26.3%
15/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
24.6%
14/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
5/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
7.0%
4/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
70.2%
40/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Skin infection
|
12.3%
7/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Urinary tract infection
|
8.8%
5/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
17.5%
10/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
17.5%
10/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
14.0%
8/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Blood bilirubin increased
|
10.5%
6/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Investigations-Other, specify: Total protein, low
|
26.3%
15/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
10.5%
6/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight loss
|
7.0%
4/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Investigations
White blood cell decreased
|
12.3%
7/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
19.3%
11/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.4%
23/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.1%
16/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.5%
10/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.0%
4/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.8%
13/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.3%
11/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Ataxia
|
29.8%
17/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
35.1%
20/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dizziness
|
29.8%
17/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysphasia
|
22.8%
13/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
35.1%
20/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Memory impairment
|
43.9%
25/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders-Other, specify: Mood Alteration, NOS
|
14.0%
8/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
45.6%
26/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.3%
15/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Pyramidal tract syndrome
|
7.0%
4/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Seizure
|
22.8%
13/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Tremor
|
24.6%
14/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Agitation
|
14.0%
8/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Anxiety
|
24.6%
14/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
35.1%
20/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Depression
|
15.8%
9/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
42.1%
24/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Libido decreased
|
5.3%
3/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary incontinence
|
8.8%
5/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders-Other, specify: Sexual Dysfunction
|
19.3%
11/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.3%
15/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.8%
5/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
77.2%
44/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypertension
|
14.0%
8/57 • The length of time that the subjects were receiving treatment and then 30 days after treatment termination.
Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place