Trial Outcomes & Findings for A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme (NCT NCT01268566)

Last Updated: 2017-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

6 months

Results posted on

2017-04-06

Participant Flow

A total of 56 subjects were enrolled and treated at 13 sites in the United States.

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.

Participant milestones

Participant milestones
Measure	MEDI-575, 25 mg/kg 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 Study STARTED	56
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	MEDI-575, 25 mg/kg 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 Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	12
Overall Study Death	30

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Age, Continuous	52.9 Years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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).

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Progression-free Survival Rate at 6 Months	15.4 Percentage of participants Interval 8.1 to 24.9

SECONDARY outcome

Timeframe: Study entry through the end of the study, up to 21 months

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Percentage of Participants With Best Overall Response Complete response with confirmation	0 Percentage of participants
Percentage of Participants With Best Overall Response Complete response without confirmation	0 Percentage of participants
Percentage of Participants With Best Overall Response Partial response with confirmation	0 Percentage of participants
Percentage of Participants With Best Overall Response Partial response without confirmation	0 Percentage of participants
Percentage of Participants With Best Overall Response Stable disease	41.1 Percentage of participants
Percentage of Participants With Best Overall Response Progressive disease	55.4 Percentage of participants
Percentage of Participants With Best Overall Response Unknown	3.6 Percentage of participants

SECONDARY outcome

Timeframe: Study entry through the end of the study, up to 21 months

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Percentage of Participants With Objective Response	0 Percentage of participants Interval 0.0 to 5.2

SECONDARY outcome

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study entry until the first documented disease progression, up to 16 months

Population: ITT population. N= number of participants analyzed for this outcome measure

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=48 Participants 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.
Time to Progression	1.4 Months Interval 1.4 to 1.8

SECONDARY outcome

Timeframe: 3 months and 9 months

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Progression-free Survival Rate at 3 Months and 9 Months PFS rate at 3 months	26.5 Percentage of participants Interval 17.1 to 36.7
Progression-free Survival Rate at 3 Months and 9 Months PFS rate at 9 months	8.8 Percentage of participants Interval 3.6 to 17.1

SECONDARY outcome

Timeframe: 9 months

Population: ITT population. N= number of participants analyzed for this outcome measure

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=50 Participants 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.
Progression-free Survival	1.4 Months Interval 1.4 to 1.8

SECONDARY outcome

Timeframe: Study entry to death, up to 16 months

Population: ITT population. N= number of participants analyzed for this outcome measure

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=30 Participants 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 Survival	9.7 Months Interval 6.5 to 11.8

SECONDARY outcome

Timeframe: Screening (Day-28 to Day -1)

Population: ITT population with archived tumor samples were assessed.

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=39 Participants 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.
Percentage of Participants With Expression of PDGFR Alpha in the Tumor Samples Positive PDGFR alpha staining in tumor cells	46 Percentage of participants
Percentage of Participants With Expression of PDGFR Alpha in the Tumor Samples Positive staining in tumor stromal cells	26 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to last record on study, up to 21 months

Population: Safety population included all participants who received at least 1 dose of MEDI-575.

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Participants with TEAEs	50 Participants
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Participants with treatment emergent SAEs	17 Participants

SECONDARY outcome

Timeframe: Baseline to last record on study, up to 21 months

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Last record on-study: Not done	0 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Worst on-study: Grade 0	6 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Worst on-study: Grade 1	24 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Worst on-study: Grade 2	16 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Worst on-study: Grade 3	9 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Worst on-study: Grade 4	1 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Worst on-study: Not done	0 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Last record on-study: Grade 0	9 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Last record on-study: Grade 1	27 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Last record on-study: Grade 2	12 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Last record on-study: Grade 3	7 Participants
Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study Last record on-study: Grade 4	1 Participants

SECONDARY outcome

Timeframe: Baseline to last record on study, up to 21 months

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Treatment-emergent Adverse Events Related to Laboratory Parameters Anaemia	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Thrombocytopenia	2 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Activated partial thromboplastin time prolonged	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Lymphocyte count decreased	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Platelet count decreased	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters White blood cell count increased	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Blood lactate dehydrogenase increased	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Hypokalaemia	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Hypomagnesaemia	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Hypophosphataemia	1 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Haematuria	2 Participants
Treatment-emergent Adverse Events Related to Laboratory Parameters Urinary tract infection	4 Participants

SECONDARY outcome

Timeframe: Baseline to last record on study, up to 21 months

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations Abnormal ECG T wave	1 Participants
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations Bradycardia	1 Participants
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations Sinus bradycardia	1 Participants

SECONDARY outcome

Timeframe: Baseline to last record on study, up to 21 months

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	MEDI-575, 25 mg/kg n=56 Participants 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.
Treatment-emergent Adverse Events Related to Vital Sign Parameters Hypertension	2 Participants
Treatment-emergent Adverse Events Related to Vital Sign Parameters Hypotension	2 Participants
Treatment-emergent Adverse Events Related to Vital Sign Parameters Heart rate increased	1 Participants
Treatment-emergent Adverse Events Related to Vital Sign Parameters Pyrexia	1 Participants

Adverse Events

MEDI-575, 25 mg/kg

Serious events: 17 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MEDI-575, 25 mg/kg n=56 participants at risk 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.
Cardiac disorders Cardiac failure	1.8% 1/56 • Number of events 2 • Baseline to last record on study, up to 21 months
Gastrointestinal disorders Anal fissure	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Gastrointestinal disorders Diverticular perforation	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Gastrointestinal disorders Dysphagia	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Infections and infestations Cellulitis	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Infections and infestations Pneumonia	3.6% 2/56 • Number of events 2 • Baseline to last record on study, up to 21 months
Infections and infestations Sepsis	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Injury, poisoning and procedural complications Fall	3.6% 2/56 • Number of events 2 • Baseline to last record on study, up to 21 months
Injury, poisoning and procedural complications Rib fracture	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Nervous system disorders Brain oedema	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Nervous system disorders Cerebral cyst	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Nervous system disorders Convulsion	8.9% 5/56 • Number of events 5 • Baseline to last record on study, up to 21 months
Nervous system disorders Headache	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Nervous system disorders Hydrocephalus	5.4% 3/56 • Number of events 4 • Baseline to last record on study, up to 21 months
Nervous system disorders Ischaemic stroke	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Nervous system disorders Somnolence	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Nervous system disorders Subarachnoid haemorrhage	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Psychiatric disorders Confusional state	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Psychiatric disorders Mental status changes	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Renal and urinary disorders Nephrolithiasis	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.8% 1/56 • Number of events 1 • Baseline to last record on study, up to 21 months

Other adverse events

Other adverse events
Measure	MEDI-575, 25 mg/kg n=56 participants at risk 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.
Gastrointestinal disorders Constipation	7.1% 4/56 • Number of events 5 • Baseline to last record on study, up to 21 months
Gastrointestinal disorders Diarrhoea	23.2% 13/56 • Number of events 18 • Baseline to last record on study, up to 21 months
Gastrointestinal disorders Nausea	23.2% 13/56 • Number of events 16 • Baseline to last record on study, up to 21 months
Gastrointestinal disorders Vomiting	7.1% 4/56 • Number of events 4 • Baseline to last record on study, up to 21 months
General disorders Fatigue	28.6% 16/56 • Number of events 19 • Baseline to last record on study, up to 21 months
General disorders Gait disturbance	10.7% 6/56 • Number of events 6 • Baseline to last record on study, up to 21 months
General disorders Oedema peripheral	8.9% 5/56 • Number of events 5 • Baseline to last record on study, up to 21 months
Infections and infestations Sinusitis	5.4% 3/56 • Number of events 3 • Baseline to last record on study, up to 21 months
Infections and infestations Upper respiratory tract infection	7.1% 4/56 • Number of events 4 • Baseline to last record on study, up to 21 months
Infections and infestations Urinary tract infection	7.1% 4/56 • Number of events 4 • Baseline to last record on study, up to 21 months
Metabolism and nutrition disorders Decreased appetite	7.1% 4/56 • Number of events 4 • Baseline to last record on study, up to 21 months
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 4/56 • Number of events 6 • Baseline to last record on study, up to 21 months
Nervous system disorders Aphasia	12.5% 7/56 • Number of events 9 • Baseline to last record on study, up to 21 months
Nervous system disorders Cognitive disorder	5.4% 3/56 • Number of events 3 • Baseline to last record on study, up to 21 months
Nervous system disorders Convulsion	5.4% 3/56 • Number of events 3 • Baseline to last record on study, up to 21 months
Nervous system disorders Dizziness	12.5% 7/56 • Number of events 8 • Baseline to last record on study, up to 21 months
Nervous system disorders Headache	16.1% 9/56 • Number of events 11 • Baseline to last record on study, up to 21 months
Nervous system disorders Hemiparesis	7.1% 4/56 • Number of events 4 • Baseline to last record on study, up to 21 months
Nervous system disorders Memory impairment	10.7% 6/56 • Number of events 6 • Baseline to last record on study, up to 21 months
Psychiatric disorders Confusional state	5.4% 3/56 • Number of events 3 • Baseline to last record on study, up to 21 months
Psychiatric disorders Insomnia	10.7% 6/56 • Number of events 6 • Baseline to last record on study, up to 21 months
Respiratory, thoracic and mediastinal disorders Cough	7.1% 4/56 • Number of events 4 • Baseline to last record on study, up to 21 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 3/56 • Number of events 3 • Baseline to last record on study, up to 21 months

Additional Information

A Phase 2 Study of MEDI-575 in Adult Subjects with Recurrent Glioblastoma Multiforme

MedImmune, LLC, an affiliate of AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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