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A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT01268566
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Intervention Drug: MEDI-575
Enrollment 62
Recruitment Details A total of 56 subjects were enrolled and treated at 13 sites in the United States.
Pre-assignment Details A total of 62 participants were screened. Of which, 56 participants were enrolled into study as 5 participants failed screening and 1 participant withdrew consent.
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Period Title: Overall Study
Started 56
Completed 13
Not Completed 43
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             12
Death             30
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
52.9  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
19
  33.9%
Male
37
  66.1%
1.Primary Outcome
Title Progression-free Survival Rate at 6 Months
Hide Description Progression-free survival (PFS) rate at 6 months is defined as the proportion of participants who neither progressed nor died before 6 months after the first dose. Progression was determined using Updated Response Assessment Criteria of High Grade Gliomas: Response Assessment in Neuro-Oncology Working Group (RANO criteria). Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/fluid attenuated inversion recovery (FLAIR) nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS-6 was estimated using Kaplan-Meier method.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to treat (ITT) population: All participants who entered into the study (ie, participants for whom investigator notified the interactive web response system [IWRS] that the participant met eligibility criteria and the IWRS assigned unblinded study drug to the participant).
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
15.4
(8.1 to 24.9)
2.Secondary Outcome
Title Percentage of Participants With Best Overall Response
Hide Description Best overall response rate is calculated based upon the disease assessments recorded during the study visits using RANO criteria. Best overall response includes complete response (CR), CR with confirmation, partial response (PR), PR with confirmation, stable disease and progressive disease. Confirmed responses are those that persist on repeat imaging studies at least 4 weeks after the initial documentation of response.
Time Frame Study entry through the end of the study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Percentage of participants
Complete response with confirmation 0
Complete response without confirmation 0
Partial response with confirmation 0
Partial response without confirmation 0
Stable disease 41.1
Progressive disease 55.4
Unknown 3.6
3.Secondary Outcome
Title Percentage of Participants With Objective Response
Hide Description Objective response rate (ORR) is defined as the proportion of participants with confirmed CR or confirmed PR using RANO criteria. Confirmed CR and PR are those that persist on repeat imaging study for at least 4 weeks after the initial documentation of the response. CR is defined as complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, patient is off corticosteroids and stable or improved clinically. PR is defined as 50% decrease compared with baseline in the measurement of all measurable enhancing lesions sustained for at least 4 weeks, no progression of nonmeasurable disease, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, no increase in the corticosteroid dose and stable or improved clinically.
Time Frame Study entry through the end of the study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0.0 to 5.2)
4.Secondary Outcome
Title Time to Response
Hide Description Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was estimated using Kaplan-Meier method.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with an objective response (ie, confirmed CR or PR) were assessed. TTR was not estimable as there were no participants with an objective response.
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. Duration of response was estimated using Kaplan-Meier method and evaluated only for the participants of subgroup with an objective response.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with an objective response (ie, confirmed CR or PR) were assessed. Duration of response was not estimable as there were no participants with an objective response.
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Progression
Hide Description Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression was defined by at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. TTP was estimated using Kaplan-Meier method.
Time Frame Study entry until the first documented disease progression, up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. N= number of participants analyzed for this outcome measure
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 48
Median (90% Confidence Interval)
Unit of Measure: Months
1.4
(1.4 to 1.8)
7.Secondary Outcome
Title Progression-free Survival Rate at 3 Months and 9 Months
Hide Description PFS rate at 3 and 9 months is defined as proportion of participants who neither progressed nor died due to any cause, whichever occurred first after first dose at 3 months and 9 months, respectively. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. Proportion of participants with PFS at 3 and 9 months were estimated using Kaplan-Meier method.
Time Frame 3 months and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
PFS rate at 3 months
26.5
(17.1 to 36.7)
PFS rate at 9 months
8.8
(3.6 to 17.1)
8.Secondary Outcome
Title Progression-free Survival
Hide Description PFS was measured from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Time to PFS was estimated using Kaplan-Meier method.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. N= number of participants analyzed for this outcome measure
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 50
Median (90% Confidence Interval)
Unit of Measure: Months
1.4
(1.4 to 1.8)
9.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, Overall survival was censored on the last date when participants were known to be alive. The Overall survival was estimated using the Kaplan-Meier method.
Time Frame Study entry to death, up to 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. N= number of participants analyzed for this outcome measure
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 30
Median (90% Confidence Interval)
Unit of Measure: Months
9.7
(6.5 to 11.8)
10.Secondary Outcome
Title Percentage of Participants With Expression of PDGFR Alpha in the Tumor Samples
Hide Description MEDI-575 (study drug) blocks platelet-derived growth factor (PDGF) binding to PDGF receptor (PDGFR) alpha and inhibits signaling. The tissue samples which were collected prior to the study entry (archived tumor samples) were evaluated by immunohistochemistry staining for expression of PDGFR alpha signaling protein that are targets of MEDI-575. Expression of PDGFR alpha in tumor cells and tumor-associated stromal cells were evaluated for intensity and distribution of staining. The percentage of participants with positive PDGFR alpha staining in the tumor cells and tumor-associated stromal cells were reported.
Time Frame Screening (Day-28 to Day -1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with archived tumor samples were assessed.
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: Percentage of participants
Positive PDGFR alpha staining in tumor cells 46
Positive staining in tumor stromal cells 26
11.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
Hide Description An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are AEs occurring or worsening after the administration of study drug until 90 days after the last dose of study drug or until the participant began another anticancer therapy, which ever came first. A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. The TEAEs and SAEs were summarized using MedDRA version 15.1. Participants were counted only once for each event, regardless of number of events the participant had.
Time Frame Baseline to last record on study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of MEDI-575.
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Participants with TEAEs 50
Participants with treatment emergent SAEs 17
12.Secondary Outcome
Title Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study
Hide Description Eastern Cooperative Oncology Group (ECOG) performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (fully active ie, best) to 5 (dead ie, worst). Following are ECOG grades: 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead.
Time Frame Baseline to last record on study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Worst on-study: Grade 0 6
Worst on-study: Grade 1 24
Worst on-study: Grade 2 16
Worst on-study: Grade 3 9
Worst on-study: Grade 4 1
Worst on-study: Not done 0
Last record on-study: Grade 0 9
Last record on-study: Grade 1 27
Last record on-study: Grade 2 12
Last record on-study: Grade 3 7
Last record on-study: Grade 4 1
Last record on-study: Not done 0
13.Secondary Outcome
Title Treatment-emergent Adverse Events Related to Laboratory Parameters
Hide Description Laboratory evaluations of blood and urine samples were performed, including hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count with differential); serum chemistry (calcium, chloride, magnesium, potassium, sodium, aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma glutamyl transferase, lactic dehydrogenase, carbon dioxide/bicarbonate, blood urea nitrogen, uric acid, creatinine, total bilirubin, glucose, albumin, total protein, triglycerides, cholesterol, phosphorous); urinalysis (pH, protein, blood, glucose, ketones, bilirubin); and coagulation parameters. Abnormal laboratory finding that required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation, was reported as an AE. Number of participants with TEAEs related to laboratory evaluations were reported.
Time Frame Baseline to last record on study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Anaemia 1
Thrombocytopenia 2
Activated partial thromboplastin time prolonged 1
Lymphocyte count decreased 1
Platelet count decreased 1
White blood cell count increased 1
Blood lactate dehydrogenase increased 1
Hypokalaemia 1
Hypomagnesaemia 1
Hypophosphataemia 1
Haematuria 2
Urinary tract infection 4
14.Secondary Outcome
Title Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations
Hide Description All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time period) and analyzed. Number of participants with TEAEs related to ECG after the start of study drug administration were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.
Time Frame Baseline to last record on study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Abnormal ECG T wave 1
Bradycardia 1
Sinus bradycardia 1
15.Secondary Outcome
Title Treatment-emergent Adverse Events Related to Vital Sign Parameters
Hide Description Vital sign assessments were conducted throughout the study and included body temperature, blood pressure (seated), pulse rate and respiratory rate. The TEAEs related to vital signs in participants were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.
Time Frame Baseline to last record on study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description:
MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Hypertension 2
Hypotension 2
Heart rate increased 1
Pyrexia 1
Time Frame Baseline to last record on study, up to 21 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MEDI-575, 25 mg/kg
Hide Arm/Group Description MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
All-Cause Mortality
MEDI-575, 25 mg/kg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MEDI-575, 25 mg/kg
Affected / at Risk (%) # Events
Total   17/56 (30.36%)    
Cardiac disorders   
Cardiac failure  1  1/56 (1.79%)  2
Gastrointestinal disorders   
Anal fissure  1  1/56 (1.79%)  1
Diverticular perforation  1  1/56 (1.79%)  1
Dysphagia  1  1/56 (1.79%)  1
Infections and infestations   
Cellulitis  1  1/56 (1.79%)  1
Pneumonia  1  2/56 (3.57%)  2
Sepsis  1  1/56 (1.79%)  1
Injury, poisoning and procedural complications   
Fall  1  2/56 (3.57%)  2
Rib fracture  1  1/56 (1.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Glioblastoma multiforme  1  1/56 (1.79%)  1
Nervous system disorders   
Brain oedema  1  1/56 (1.79%)  1
Cerebral cyst  1  1/56 (1.79%)  1
Convulsion  1  5/56 (8.93%)  5
Headache  1  1/56 (1.79%)  1
Hydrocephalus  1  3/56 (5.36%)  4
Ischaemic stroke  1  1/56 (1.79%)  1
Somnolence  1  1/56 (1.79%)  1
Subarachnoid haemorrhage  1  1/56 (1.79%)  1
Psychiatric disorders   
Confusional state  1  1/56 (1.79%)  1
Mental status changes  1  1/56 (1.79%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/56 (1.79%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MEDI-575, 25 mg/kg
Affected / at Risk (%) # Events
Total   43/56 (76.79%)    
Gastrointestinal disorders   
Constipation  1  4/56 (7.14%)  5
Diarrhoea  1  13/56 (23.21%)  18
Nausea  1  13/56 (23.21%)  16
Vomiting  1  4/56 (7.14%)  4
General disorders   
Fatigue  1  16/56 (28.57%)  19
Gait disturbance  1  6/56 (10.71%)  6
Oedema peripheral  1  5/56 (8.93%)  5
Infections and infestations   
Sinusitis  1  3/56 (5.36%)  3
Upper respiratory tract infection  1  4/56 (7.14%)  4
Urinary tract infection  1  4/56 (7.14%)  4
Metabolism and nutrition disorders   
Decreased appetite  1  4/56 (7.14%)  4
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  4/56 (7.14%)  6
Nervous system disorders   
Aphasia  1  7/56 (12.50%)  9
Cognitive disorder  1  3/56 (5.36%)  3
Convulsion  1  3/56 (5.36%)  3
Dizziness  1  7/56 (12.50%)  8
Headache  1  9/56 (16.07%)  11
Hemiparesis  1  4/56 (7.14%)  4
Memory impairment  1  6/56 (10.71%)  6
Psychiatric disorders   
Confusional state  1  3/56 (5.36%)  3
Insomnia  1  6/56 (10.71%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/56 (7.14%)  4
Oropharyngeal pain  1  3/56 (5.36%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: A Phase 2 Study of MEDI-575 in Adult Subjects with Recurrent Glioblastoma Multiforme
Organization: MedImmune, LLC, an affiliate of AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01268566     History of Changes
Other Study ID Numbers: CD-ON-MEDI-575-1042
First Submitted: December 29, 2010
First Posted: December 31, 2010
Results First Submitted: December 21, 2016
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017