A Phase 1 Study to Evaluate the Safety, Tolerability, and... | NCT01577745 | Trialant
NCT01577745
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
May 2, 2017Actual
Enrollment
58Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
MEDI0639
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01577745
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CD-ON-MEDI0639-1078
Secondary IDs
Not provided
Brief Title
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors
Official Title
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Adult Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2012
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
First Submitted Date
Apr 5, 2012
First Submission Date that Met QC Criteria
Apr 12, 2012
First Posted Date
Apr 16, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 23, 2017
Results First Submitted that Met QC Criteria
Mar 21, 2017
Results First Posted Date
May 2, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 21, 2017
Last Update Posted Date
May 2, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI0639.
Detailed Description
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK, and immunogenicity of MEDI0639 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exist. Up to 63 subjects will be enrolled at approximately 3 to 5 study centers in North America.
Conditions Module
Conditions
Solid Tumors
Keywords
Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
58Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI0639 Cohort 1
Experimental
Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
Biological: MEDI0639
MEDI0639 Cohort 2
Experimental
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Biological: MEDI0639
MEDI0639 Cohort 3
Experimental
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Biological: MEDI0639
MEDI0639 Cohort 4
Experimental
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Biological: MEDI0639
MEDI0639 Cohort 5
Experimental
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Biological: MEDI0639
MEDI0639 Cohort 6
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI0639
Biological
MEDI0639 is an immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. MEDI0639 selectively binds to DLL4 and blocks its ability to bind to and activate signaling through the Notch receptors.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of MEDI0639
The MTD evaluation was based on the dose-limiting toxicity (DLT) evaluable population. DLT is defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period (defined as the time from the first dose of MEDI0639 to 21 days after the first dose), except for National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hypertension that could be controlled within 96 hours; Grade 3 symptomatic hypertension of greater than (>) 180 millimetre of mercury (mm Hg) systolic or >120 mm Hg diastolic or asymptomatic hypertension of >200 mm Hg systolic or >120 mm Hg diastolic was considered a DLT.
From the first dose of MEDI0639 to 21 days after the first dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the last dose of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.
From the first dose of MEDI0639 until 90 days after the last dose of MEDI0639. Maximum time frame across participants was 11 months.
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
A serious AE (SAE) is any AE that results in death (refers to an event, which risk of death at the time of the event; it does not refer to an event that may have led to 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. Treatment-emergent SAEs defined as SAEs present at baseline that worsened in intensity after administration of study drug or SAEs absent at baseline that emerged after administration of study drug. The SAEs were summarized using MedDRA version 18.1.
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed solid tumors that are refractory to standard therapy or for which no standard therapy exist
Age ≥ 18 years
ECOG Performance Status of 0 or 1
LVEF (measured by Echocardiogram) > 50%
No gastrointestinal bleeding within 1 year of study entry.
Adequate organ and marrow function:
Hemoglobin ≥ 10g/dL
Absolute Neutrophil Count ≥ 1500/mm3
Platelet Count ≥ 100,000/mm3
AST & ALT ≤ 2.5 x ULN
Bilirubin ≤ 1.5 x ULN
Cr Cl ≥ 50 mL/min (as determined by the Cockcroft-Gault equation or by 24-hour urine collection)
Prior therapy against VEGF or VEGFRs including, but not limited to bevacizumab, sunitinib, sorafenib, pazopanib, motesanib (AMG706), or cediranib (AZD2171), is permitted so long as the agent does not have any known activity against DLL4 and the last dose received s at least 6 weeks prior to first dose of MEDI0639.
Life expectancy ≥ 12 weeks
Females of childbearing potential must be surgically sterile, have a sterile male partner, be premenarchal or at least 2 years postmenopausal, practice abstinence or otherwise must use 2 effective methods of contraception from the time of initiation of investigational product.
Males, unless surgically sterile, must use 2 effective methods of contraception with a female partner and must agree to continue using such contraception for 90 days after the last dose of MEDI0639
Exclusion Criteria:
Concurrent enrollment in another investigational clinical study
Receipt of any investigational anticancer therapy within 4 weeks prior to the first dose of MEDI0639 or in the case of monoclonal antibodies, 6 weeks prior to the first dose of MEDI0639
Concurrent or previous treatment with inhibitors of DLL4
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
Known bleeding diathesis, esophageal varices, or angioplasty
Pulmonary hemorrhage or gross hemoptysis within 12 months
Known arterial or venous thrombosis or pulmonary embolism within 2 years
Concurrent use of systemic low molecular weight heparin or low dose warfarin
Presence of brain metastases
Cerebrovascular accident or transient ischemic attack within 2 years
Cardiovascular events, such as myocardial infarction, unstable/severe angina, coronary/peripheral artery bypass graft, unstable cardiac arrhythmia requiring medication, congestive heart failure (NYHA > class II), within 2 years
Tumors with squamous cell histology
Major surgical procedure within 90 days
Pregnancy or lactation
Known HIV positive or Hepatitis A, B, or C infection
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Los Angeles
California
90404
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 58 participants were screened for this study, of which 25 participants were enrolled and received study treatment.
Recruitment Details
A total of 58 participants were screened at 7 sites in the United States of America (USA).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
FG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
Biological: MEDI0639
MEDI0639 Cohort 1
MEDI0639 Cohort 2
MEDI0639 Cohort 3
MEDI0639 Cohort 4
MEDI0639 Cohort 5
MEDI0639 Cohort 6
From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Laboratory Parameters
Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, potassium, sodium, bicarbonate, aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, total bilirubin, liver function test, gamma glutamyl transferase [GGT], lactate dehydrogenase, uric acid, creatinine, blood urea nitrogen [BUN], glucose, albumin, total protein, triglycerides, cholesterol, and troponin); and routine urinalysis. The TEAEs related to laboratory evaluations in participants were reported.
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and Physical Examination
Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed at baseline and throughout the study. The TEAEs related to vital signs in participants were reported.
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (ECG) Evaluations
ECG parameters included QT interval and corrected QT (QTc) interval. Electrocardiogram (ECG) parameters were assessed at baseline as well as throughout the study. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to ECG evaluations in participants were reported.
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Echocardiogram Evaluations
Echocardiogram parameters included left ventricular ejection fraction (LVEF) and pulmonary arterial pressure (PAP). The TEAEs related to echocardiogram evaluations in participants were reported.
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
Maximum Observed Concentration (Cmax) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
Clearance (CL) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639. Clearance was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity.
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
Half-life (t1/2) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
Number of Participants Positive With Antidrug Antibodies (ADA) for MEDI0639
Blood samples were measured for the presence of ADA for MEDI0639 using a validated bridging immunoassay. Only the number of participants positive for anti-MEDI-575 antibodies at any visit were presented.
On Day 1 of Cycles 1, 2, 3, and every other cycle thereafter, end of treatment, 30 days, and 3 and 6 months after the last dose of MEDI0639. Maximum time frame across participants was 14 months.
Percentage of Participants With Best Overall Response
Percentage (%) of participants who were responders with BOR documented as confirmed CR, PR, stable disease (SD), progressive disease (PD) and non-evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. PR: At least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From study entry through the end of the study. Maximum time frame across participants was 4 years.
Percentage of Participants With Objective Response
Objective response rate (ORR) defined as the percentage of participants with a BOR of confirmed CR or confirmed PR.
From study entry through the end of the study. Maximum time frame across participants was 4 years.
Percentage of Participants With Disease Control
Disease control rate (DCR) defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or SD.
From study entry through the end of the study. Maximum time frame across participants was 4 years.
Time to Response
Time to response (TTR) defined as the time from the first dose of MEDI0639 until the first documentation of a subsequently confirmed objective response. Only participants who have achieved objective response (confirmed CR or confirmed PR) was evaluated for TTR. TTR (months) = (Date of first disease response - Date of the first dose of MEDI0639 + 1) / (365.25/12).
From study entry through the end of the study. Maximum time frame across participants was 4 years.
Duration of Response (DR)
DR defined as time from start of first documented objective response [confirmed Complete Response (CR) or confirmed Partial Response (PR)] to first documented disease progression or death due to any cause, whichever occurs first. DR calculated as (months) = (Date of PD/death or censoring - Date of first disease response + 1)/ (365.25/12).
From study entry through the end of the study. Maximum time frame across participants was 4 years.
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of MEDI0639 until the first documentation of disease progression or death due to any cause, whichever occurs first. PFS (months) = (Date of PD/death or censoring - Date of the first dose of MEDI0639 + 1) / (365.25/12).
From study entry through the end of the study. Maximum time frame across participants was 4 years.
Overall Survival
Overall survival defined as the time from the first dose of MEDI0639 until death due to any cause. OS (months) = (Date of death or censoring - Date of the first dose of MEDI0639 + 1) / (365.25/12).
From study entry through the end of the study. Maximum time frame across participants was 4 years.
New Haven
Connecticut
06513
United States
Research Site
Boston
Massachusetts
United States
Research Site
Ann Arbor
Michigan
48103
United States
Research Site
Minneapolis
Minnesota
United States
Research Site
New York
New York
10002
United States
Research Site
Cincinnati
Ohio
45201
United States
Research Site
Cleveland
Ohio
44105
United States
Research Site
Houston
Texas
77030
United States
Research Site
Seattle
Washington
98112
United States
Research Site
Tacoma
Washington
98405
United States
FG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
FG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
FG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
FG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG0045 subjects
FG0055 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG0036 subjects
FG0045 subjects
FG0054 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG0042 subjects
FG0050 subjects
Death
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Alternative Therapy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Safety Population included all participants who received at least one dose of MEDI0639.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
BG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
BG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
BG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
BG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
BG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0036
BG0045
BG0055
BG00625
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00055.7± 14.0
BG00157.3± 22.5
BG00267.7± 13.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Tolerated Dose (MTD) of MEDI0639
The MTD evaluation was based on the dose-limiting toxicity (DLT) evaluable population. DLT is defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period (defined as the time from the first dose of MEDI0639 to 21 days after the first dose), except for National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hypertension that could be controlled within 96 hours; Grade 3 symptomatic hypertension of greater than (>) 180 millimetre of mercury (mm Hg) systolic or >120 mm Hg diastolic or asymptomatic hypertension of >200 mm Hg systolic or >120 mm Hg diastolic was considered a DLT.
All participants enrolled in the dose-escalation phase who received at least 1 full cycle of MEDI0639 and completed safety follow-up through the DLT evaluation period or experienced any DLT.
Posted
Number
milligram (mg)
From the first dose of MEDI0639 to 21 days after the first dose
ID
Title
Description
OG000
MEDI0639
Participants received MEDI0639, in dose escalation phase starting from dose level 1 to 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00025
Title
Denominators
Categories
Title
Measurements
OG000NAThere were no participants with DLTs, hence MTD was not identified. The maximum administered dose was 200 mg.
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the last dose of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.
All participants who received at least one dose of MEDI0639.
Posted
Number
participants
From the first dose of MEDI0639 until 90 days after the last dose of MEDI0639. Maximum time frame across participants was 11 months.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Primary
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
A serious AE (SAE) is any AE that results in death (refers to an event, which risk of death at the time of the event; it does not refer to an event that may have led to 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. Treatment-emergent SAEs defined as SAEs present at baseline that worsened in intensity after administration of study drug or SAEs absent at baseline that emerged after administration of study drug. The SAEs were summarized using MedDRA version 18.1.
All participants who received at least one dose of MEDI0639.
Posted
Number
Participants
From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Laboratory Parameters
Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, potassium, sodium, bicarbonate, aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, total bilirubin, liver function test, gamma glutamyl transferase [GGT], lactate dehydrogenase, uric acid, creatinine, blood urea nitrogen [BUN], glucose, albumin, total protein, triglycerides, cholesterol, and troponin); and routine urinalysis. The TEAEs related to laboratory evaluations in participants were reported.
All participants who received at least one dose of MEDI0639.
Posted
Number
Participants
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and Physical Examination
Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed at baseline and throughout the study. The TEAEs related to vital signs in participants were reported.
All participants who received at least one dose of MEDI0639.
Posted
Number
Participants
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (ECG) Evaluations
ECG parameters included QT interval and corrected QT (QTc) interval. Electrocardiogram (ECG) parameters were assessed at baseline as well as throughout the study. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to ECG evaluations in participants were reported.
All participants who received at least one dose of MEDI0639.
Posted
Number
Participants
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Echocardiogram Evaluations
Echocardiogram parameters included left ventricular ejection fraction (LVEF) and pulmonary arterial pressure (PAP). The TEAEs related to echocardiogram evaluations in participants were reported.
All participants who received at least one dose of MEDI0639.
Posted
Number
Participants
From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Secondary
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.
All the participants who received dose of MEDI0639 in Cycle 1 and for whom Pharmacokinetic (PK) blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
microgram*day per milliliter (mcg*d/mL)
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Secondary
Maximum Observed Concentration (Cmax) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.
All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
microgram per milliliter (mcg/mL)
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
Secondary
Clearance (CL) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639. Clearance was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity.
All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
Liter per day (L/d)
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Secondary
Half-life (t1/2) After Cycle 1 Treatment Administration of MEDI0639
The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.
All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.
Posted
Mean
Standard Deviation
Days
Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Secondary
Number of Participants Positive With Antidrug Antibodies (ADA) for MEDI0639
Blood samples were measured for the presence of ADA for MEDI0639 using a validated bridging immunoassay. Only the number of participants positive for anti-MEDI-575 antibodies at any visit were presented.
All participants who received any treatment with MEDI0639.
Posted
Number
Participants
On Day 1 of Cycles 1, 2, 3, and every other cycle thereafter, end of treatment, 30 days, and 3 and 6 months after the last dose of MEDI0639. Maximum time frame across participants was 14 months.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Secondary
Percentage of Participants With Best Overall Response
Percentage (%) of participants who were responders with BOR documented as confirmed CR, PR, stable disease (SD), progressive disease (PD) and non-evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. PR: At least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All participants who received at least one dose of MEDI0639.
Posted
Number
Percentage of Participants
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Secondary
Percentage of Participants With Objective Response
Objective response rate (ORR) defined as the percentage of participants with a BOR of confirmed CR or confirmed PR.
All participants who received at least one dose of MEDI0639. All participants with an objective response were included.
Posted
Number
95% Confidence Interval
Percentage of Participants
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle..
Secondary
Percentage of Participants With Disease Control
Disease control rate (DCR) defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or SD.
All participants who received at least one dose of MEDI0639.
Posted
Number
95% Confidence Interval
Percentage of Participants
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Secondary
Time to Response
Time to response (TTR) defined as the time from the first dose of MEDI0639 until the first documentation of a subsequently confirmed objective response. Only participants who have achieved objective response (confirmed CR or confirmed PR) was evaluated for TTR. TTR (months) = (Date of first disease response - Date of the first dose of MEDI0639 + 1) / (365.25/12).
All participants who received at least one dose of MEDI0639. All participants with an objective response were included.
Posted
Median
95% Confidence Interval
Months
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
Secondary
Duration of Response (DR)
DR defined as time from start of first documented objective response [confirmed Complete Response (CR) or confirmed Partial Response (PR)] to first documented disease progression or death due to any cause, whichever occurs first. DR calculated as (months) = (Date of PD/death or censoring - Date of first disease response + 1)/ (365.25/12).
All participants who received at least one dose of MEDI0639. All participants with an objective response were included.
Posted
Median
95% Confidence Interval
Months
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
Secondary
Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of MEDI0639 until the first documentation of disease progression or death due to any cause, whichever occurs first. PFS (months) = (Date of PD/death or censoring - Date of the first dose of MEDI0639 + 1) / (365.25/12).
All participants who received at least one dose of MEDI0639.
Posted
Median
95% Confidence Interval
Months
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Secondary
Overall Survival
Overall survival defined as the time from the first dose of MEDI0639 until death due to any cause. OS (months) = (Date of death or censoring - Date of the first dose of MEDI0639 + 1) / (365.25/12).
All participants who received at least one dose of MEDI0639.
Posted
Median
95% Confidence Interval
Months
From study entry through the end of the study. Maximum time frame across participants was 4 years.
ID
Title
Description
OG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Time Frame
AEs collected from first dose of MEDI0639 to 90 days post dose of MEDI0639, max time frame across participants was 11 months. SAEs collected from the first dose of MEDI0639 to end of participation in study; max time frame across participants was 4 yrs.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MEDI0639 Cohort 1
Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
2
3
3
3
EG001
MEDI0639 Cohort 2
Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
1
3
3
3
EG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
2
3
3
3
EG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
2
6
6
6
EG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
4
5
5
5
EG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
3
5
4
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected5 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dilatation ventricular
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Ventricular hypokinesia
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Gastroenteritis pseudomonas
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0033 events3 affected6 at risk
EG0044 events3 affected5 at risk
EG0050 events0 affected5 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0025 events2 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0014 events3 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Brain natriuretic peptide increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0003 events3 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Troponin i increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0004 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
OMs relationship modulation of DLL4-Notch signaling pathway in tumor and clinical response analysis was not conducted due to low number of evaluable tumor samples and low response rate. Study was terminated early due to lack of clinical activity.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Mohammed Dar
MedImmune, LLC
301-398-1008
information.center@astrazeneca.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0053 subjects
1 subjects
FG0050 subjects
0 subjects
FG0051 subjects
1 subjects
FG0050 subjects
62.2
± 9.3
BG00462.2± 5.2
BG00562.6± 10.8
BG00661.6± 11.3
1
BG0033
BG0043
BG0053
BG00613
Male
BG0003
BG0010
BG0022
BG0033
BG0042
BG0052
BG00612
0
BG0030
BG0041
BG0050
BG0063
Not Hispanic or Latino
BG0002
BG0012
BG0023
BG0036
BG0044
BG0055
BG00622
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
White
BG0003
BG0012
BG0023
BG0036
BG0045
BG0055
BG00624
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0022
OG0032
OG0044
OG0053
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0002
OG0010
OG0020
OG0033
OG0043
OG0051
Leukocytosis
Title
Measurements
OG0001
OG0011
OG0020
OG003
Leukopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Thrombocytopenia
Title
Measurements
OG0000
OG0011
OG0020
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0022
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0001
OG0012
OG0022
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0001
OG0010
OG0022
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood cholesterol increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood creatinine increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood lactate dehydrogenase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood triglycerides increased
Title
Measurements
OG0001
OG0010
OG0021
OG003
Brain natriuretic peptide increased
Title
Measurements
OG0001
OG0011
OG0020
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0003
OG0011
OG0022
OG003
N-terminal prohormone BNP increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Troponin I increased
Title
Measurements
OG0002
OG0010
OG0020
OG003
Troponin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hepatobiliary disorders
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hyperbilirubinaemia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Metabolism and nutrition disorders
Title
Measurements
OG0002
OG0013
OG0023
OG003
Dyslipidaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercalcaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercholesterolaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperglycaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperkalaemia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hypernatraemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hyperphosphataemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertriglyceridaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hyperuricaemia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Hypoalbuminaemia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Hypocalcaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypoglycaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypomagnesaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypophosphataemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC urine positive
Title
Measurements
OG0000
OG0010
OG0021
OG003
Proteinuria
Title
Measurements
OG0001
OG0011
OG0020
OG003
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Electrocardiogram QT prolonged
Title
Measurements
OG0001
OG0011
OG0020
OG0032
OG0040
OG0050
Weight decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Electrocardiogram t wave amplitude decreased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypotension
Title
Measurements
OG0000
OG0011
OG0021
OG003
Pyrexia
Title
Measurements
OG0000
OG0012
OG0020
OG003
Atrial fibrillation
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypertension
Title
Measurements
OG0000
OG0010
OG0021
OG003
Atrioventricular block first degree
Title
Measurements
OG0000
OG0010
OG0020
OG003
Electrocardiogram ST-T change
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
ECG QT prolonged
Title
Measurements
OG0001
OG0011
OG0020
OG0032
OG0040
OG0050
Electrocardiogram t wave amplitude decreased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Atrial fibrillation
Title
Measurements
OG0000
OG0010
OG0021
OG003
Atrioventricular block first degree
Title
Measurements
OG0000
OG0010
OG0020
OG003
Electrocardiogram ST-T change
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0007.41± 1.04
OG00141.1± 34.0
OG00289.9± 64.9
OG003179± 59.9
OG004434± 91.9
OG005512± 250
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0003.19± 0.759
OG00111.8± 2.45
OG00218.3± 4.96
OG00327.2± 7.32
OG00460.5± 13.5
OG00581.6± 47.3
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0001.37± 0.182
OG0011.06± 0.602
OG0020.895± 0.480
OG0030.619± 0.230
OG0040.360± 0.0860
OG0050.504± 0.330
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0001.50± 0.193
OG0012.53± 0.580
OG0025.09± 3.43
OG0036.42± 1.93
OG0049.74± 2.26
OG0058.25± 3.11
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
MEDI0639 Cohort 3
Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG003
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Partial Response (PR)
Title
Measurements
OG0000
OG0010
OG00233.3
OG003
Stable Disease (SD)
Title
Measurements
OG00066.7
OG00133.3
OG00233.3
OG003
Progressive Disease (PD)
Title
Measurements
OG00033.3
OG00166.7
OG00233.3
OG003
Non-Evaluable (NE)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG004
MMEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MMEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 70.8)
OG0010(0.0 to 70.8)
OG00233.3(0.8 to 90.6)
OG0030(0.0 to 45.9)
OG0040(0.0 to 52.2)
OG0050(0.0 to 52.2)
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00066.7(9.4 to 99.2)
OG00133.3(0.8 to 90.6)
OG00266.7(9.4 to 99.2)
OG00333.3(4.3 to 77.7)
OG00480.0(28.4 to 99.5)
OG0050(0.0 to 52.2)
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0021.3(NA to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
MEDI0639 Cohort 4
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0025.9(NA to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0005.1(1.2 to 5.1)
OG0011.3(1.3 to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
OG0027.1(1.3 to 7.2)
OG0031.3(0.7 to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
OG0044.8(1.4 to 4.8)
OG0050.9(0.7 to 1.4)
OG004
MEDI0639 Cohort 5
Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
OG005
MEDI0639 Cohort 6
Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0006.1(5.1 to 7.2)
OG001NA(7.8 to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
OG00228.9(13.8 to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
OG003NA(3.5 to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
OG00419.9(NA to NA)Not evaluable due to insufficient numbers of participants achieved endpoint
OG0053.0(1.1 to NA)Not evaluable due to insufficient numbers of participants achieved endpoint