A Study of R1507 in Participants With Recurrent or Refrac... | NCT00642941 | Trialant
NCT00642941
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Feb 3, 2021Actual
Enrollment
317Actual
Phase
Phase 2
Conditions
Sarcoma
Interventions
RG1507
Countries
United States
Australia
Canada
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00642941
Obsolete or Duplicate NCT IDs
NCT00615680
Organization Study
NO21157
Secondary IDs
ID
Type
Description
Link
SARC011
2007-003940-30
EudraCT Number
Brief Title
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
Official Title
A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was closed to further enrollment due to the decision by the Sponsor to discontinue development of R1507.
Expanded Access Info
No
Start Date
Dec 18, 2007Actual
Primary Completion Date
Feb 19, 2014Actual
Completion Date
Feb 19, 2014Actual
First Submitted Date
Mar 19, 2008
First Submission Date that Met QC Criteria
Mar 19, 2008
First Posted Date
Mar 25, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2020
Results First Submitted that Met QC Criteria
Jan 14, 2021
Results First Posted Date
Feb 3, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 2, 2016
Certification/Extension First Submitted that Passed QC Review
Nov 2, 2016
Certification/Extension First Posted Date
Nov 3, 2016Estimated
Last Update Submitted Date
Jan 14, 2021
Last Update Posted Date
Feb 3, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Name
Class
Sarcoma Alliance for Research through Collaboration
OTHER
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.
Detailed Description
Not provided
Conditions Module
Conditions
Sarcoma
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
317Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Ewings Sarcoma Primary Cohort
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Drug: RG1507
Cohort 2: Ewings Sarcoma Secondary Cohort
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Drug: RG1507
Cohort 3: Ewings Sarcoma Expanded Cohort
Experimental
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
Drug: RG1507
Cohort 4: Osteosarcoma
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RG1507
Drug
Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Cohort 1: Ewings Sarcoma Primary Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)
Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response) at 18 weeks from start of treatment.
Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)
Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
Baseline up to 6 years
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;
Cohort 3 only: age must be >= 2 and <= 21 years
Exclusion Criteria:
clinically significant unrelated systemic illness which would compromise the participant's ability to tolerate the investigational agent, or interfere with the study procedures or results;
known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies;
treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents;
current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal or specific kinase inhibitor);
history of solid organ transplant;
other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer;
active central nervous system disease
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope National Medical Center
Duarte
California
91010
United States
UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology
A screening period was included prior to administration of study drug. Tumor scans/X-rays were to be obtained within 4 weeks, fluro-D-glucose positron emission tomography (FDG-PET) scans within 2 weeks, and Baseline laboratory evaluations within 1 week before first dose.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0.05
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
Finland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel 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 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
Drug: RG1507
Cohort 5: Synovial Sarcoma
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
Drug: RG1507
Cohort 6: Rhabdomyosarcoma
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
Drug: RG1507
Cohort 7a: Alveolar Soft Part Sarcoma
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a includes individuals with alveolar soft part sarcoma.
Drug: RG1507
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
Drug: RG1507
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
Drug: RG1507
Cohort 7d: Clear Cell Sarcoma
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
Drug: RG1507
Cohort 7e: Myxoid Liposarcoma
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
Drug: RG1507
Cohort 8: Diagnosis Not Specified
Experimental
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Drug: RG1507
Cohort 2: Ewings Sarcoma Secondary Cohort
Cohort 3: Ewings Sarcoma Expanded Cohort
Cohort 4: Osteosarcoma
Cohort 5: Synovial Sarcoma
Cohort 6: Rhabdomyosarcoma
Cohort 7a: Alveolar Soft Part Sarcoma
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Cohort 7d: Clear Cell Sarcoma
Cohort 7e: Myxoid Liposarcoma
Cohort 8: Diagnosis Not Specified
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response at 18 weeks) from start of treatment.
Baseline, every 6 weeks until disease progression (up to 18 weeks)
Percentage of Participants With AEs in Cohorts 3-8
Baseline up to 6 years
Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8
TTP is defined as the time from date of randomization until objective tumor progression. According to the WHO Response Criteria, objective tumor progression is > 25% increase in the area of one or more measurable lesions or the appearance of new lesions.
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8
FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Overall Survival (OS) in Cohorts 1 to 8
OS was measured from the time of study registration to the date of death or was censored at the date of last contact.
Baseline until death (up to 6 years)
PFS According to WHO Response Criteria in Cohorts 1 to 8
PFS is defined as the duration of time from start of treatment to time of objective progression or death.
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507
Predose (0 hours [h]), end of 60-90 minutes infusion (EOI), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)
Pharmacokinetics: Clearance (CL) of R1507
Predose (0 h), EOI (infusion over 60-90 minutes), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)
Los Angeles
California
90095-1752
United States
Sarcoma Oncology Center
Santa Monica
California
90403
United States
Stanford Comprehensive Cancer Center
Stanford
California
94305
United States
Washington Cancer Institute; Washington Hospital Center
Washington D.C.
District of Columbia
20010
United States
Kootenai Medical Center
Coeur d'Alene
Idaho
83814
United States
Johns Hopkins Hospital
Baltimore
Maryland
21287
United States
NIH/NCI
Bethesda
Maryland
20892
United States
Massachusetts General Hospital; Dana Farber Partnes Cancer Center
Boston
Massachusetts
02114
United States
Dana Farber Partners Can Ctr
Boston
Massachusetts
02115-6084
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
48109
United States
Nebraska Methodist Hospital; Onc Hem West
Omaha
Nebraska
68114
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
Albert Einstein College of Medical Pediatrics; Department of Pediatrics
The Bronx
New York
10467
United States
Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy
Charlotte
North Carolina
28203
United States
Oregon Health and Science University Cancer Institute
Portland
Oregon
97239
United States
Pennsylvania Oncology Hema Asc
Philadelphia
Pennsylvania
19106
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Texas Children's Cancer Center; Baylor College of Medicine
Houston
Texas
77030
United States
University of Texas M.D. Anderson Cancer Center
Houston
Texas
77030
United States
Huntsman Cancer Institute; Orthopedic Center
Salt Lake City
Utah
84112
United States
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne
Victoria
3000
Australia
BCCA-Vancouver Cancer Centre
Vancouver
British Columbia
V5Z 4E6
Canada
Institut Bergonie; Oncologie
Bordeaux
33076
France
Centre Oscar Lambret; Chir Cancerologie General
Lille
59000
France
Centre Leon Berard; Departement Oncologie Medicale
Lyon
69373
France
Institut Curie; Oncologie Medicale
Paris
75231
France
Institut Gustave Roussy; Service Pediatrique
Villejuif
94805
France
HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
Rotterdam
3015 CE
Netherlands
Norwegian Radium Hospital
Oslo
0310
Norway
Hospital Sant Joan De Deu
Esplugues de Llobregas
Barcelona
08950
Spain
Skånes University Hospital, Skånes Department of Onclology
Lund
221 85
Sweden
UCL Hospital NHS Trust
London
NW1 2PG
United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London
SW3 6JJ
United Kingdom
Christie Hospital NHS Trust
Manchester
M20 4BX
United Kingdom
Derived
Pappo AS, Patel SR, Crowley J, Reinke DK, Kuenkele KP, Chawla SP, Toner GC, Maki RG, Meyers PA, Chugh R, Ganjoo KN, Schuetze SM, Juergens H, Leahy MG, Geoerger B, Benjamin RS, Helman LJ, Baker LH. R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. J Clin Oncol. 2011 Dec 1;29(34):4541-7. doi: 10.1200/JCO.2010.34.0000. Epub 2011 Oct 24.
FG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
FG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
FG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
FG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
FG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
FG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
FG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
FG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
FG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
FG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
FG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
FG00070 subjects
FG00154 subjects
FG0027 subjects
FG00340 subjects
FG00425 subjects
FG00541 subjects
FG00623 subjects
FG00714 subjects
FG00811 subjects
FG0099 subjects
FG01012 subjects
FG01111 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00070 subjects
FG00154 subjects
FG0027 subjects
FG00340 subjects
FG00425 subjects
FG00541 subjects
FG00623 subjects
FG00714 subjects
FG00811 subjects
FG0099 subjects
FG01012 subjects
FG01111 subjects
Type
Comment
Reasons
Physician Decision
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
Death
FG0004 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Study closed by Sponsor
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Disease progression
FG00060 subjects
FG00150 subjects
FG0025 subjects
FG00336 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
BG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
BG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
BG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
BG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
BG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
BG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
BG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
BG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
BG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
BG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
BG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00070
BG00154
BG0027
BG00340
BG00425
BG00541
BG00623
BG00714
BG00811
BG0099
BG01012
BG01111
BG012317
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
BG00027± 10.72
BG00128.3± 12.9
BG00213.3± 3.15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00122
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
Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.
Posted
Number
Percentage of Participants
Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)
ID
Title
Description
OG000
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
OG001
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG002
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG003
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG004
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG005
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG006
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG007
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG008
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG009
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG010
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG00054
OG0010
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.11
OG0022.5
OG0034.0
OG004
Primary
Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response) at 18 weeks from start of treatment.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment.
Posted
Number
Percentage of Participants
Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Units
Counts
Participants
Primary
Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment.
Posted
Number
percentage of participants
Baseline up to 6 years
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Secondary
Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment.
Posted
Number
percentage of participants
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Units
Counts
Participants
Secondary
PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response at 18 weeks) from start of treatment.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.
Posted
Number
Percentage of Participants
Baseline, every 6 weeks until disease progression (up to 18 weeks)
ID
Title
Description
OG000
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
OG001
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
Secondary
Percentage of Participants With AEs in Cohorts 3-8
Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment.
Posted
Number
percentage of participants
Baseline up to 6 years
ID
Title
Description
OG000
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG001
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG002
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
Secondary
Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3, 7 and 8 due to no DOR data being collected for these cohorts.
Posted
Median
95% Confidence Interval
weeks
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Secondary
Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8
TTP is defined as the time from date of randomization until objective tumor progression. According to the WHO Response Criteria, objective tumor progression is > 25% increase in the area of one or more measurable lesions or the appearance of new lesions.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.
Posted
Median
95% Confidence Interval
weeks
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Secondary
Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8
FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.
Data was not collected for this endpoint.
Posted
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Secondary
Overall Survival (OS) in Cohorts 1 to 8
OS was measured from the time of study registration to the date of death or was censored at the date of last contact.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 and 7c due to no overall survival data being collected for those cohorts.
Posted
Median
95% Confidence Interval
weeks
Baseline until death (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Secondary
PFS According to WHO Response Criteria in Cohorts 1 to 8
PFS is defined as the duration of time from start of treatment to time of objective progression or death.
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.
Posted
Median
95% Confidence Interval
weeks
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Secondary
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507
Data was not collected for this pharmacokinetic endpoint.
Posted
Predose (0 hours [h]), end of 60-90 minutes infusion (EOI), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
OG002
Secondary
Pharmacokinetics: Clearance (CL) of R1507
Data was not collected for this pharmacokinetic endpoint.
Posted
Predose (0 h), EOI (infusion over 60-90 minutes), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)
ID
Title
Description
OG000
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
OG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
OG002
Time Frame
Baseline up to 6 years
Description
Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment.
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
Cohort 1: Ewings Sarcoma Primary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
9
70
11
70
67
70
EG001
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
5
54
13
54
52
54
EG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
2
7
1
7
6
7
EG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
7
40
4
40
40
40
EG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
3
25
5
25
25
25
EG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
3
41
4
41
39
41
EG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
1
23
1
23
21
23
EG007
Cohort 7b: Desmoplastic Small Round Cell Tumors
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
0
14
1
14
12
14
EG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
0
11
0
11
11
11
EG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
1
9
3
9
9
9
EG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
1
12
2
12
12
12
EG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
2
11
4
11
11
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Deep vein thrombosis
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG0030 affected40 at risk
EG0041 affected25 at risk
EG0050 affected41 at risk
EG0060 affected23 at risk
EG0070 affected14 at risk
EG0080 affected11 at risk
EG0090 affected9 at risk
EG0100 affected12 at risk
EG0110 affected11 at risk
Haemorrhage
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Thrombosis
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Inflammation
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pain
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0021 affected7 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Facial palsy
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Adrenal haemorrhage
Endocrine disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Device related infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Sepsis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Alanine aminotransferase increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0012 affected54 at risk
EG0021 affected7 at risk
EG0032 affected40 at risk
EG0043 affected25 at risk
EG0057 affected41 at risk
EG0062 affected23 at risk
EG0072 affected14 at risk
EG0080 affected11 at risk
EG0090 affected9 at risk
EG0102 affected12 at risk
EG0110 affected11 at risk
Aspartate aminotransferase increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0008 affected70 at risk
EG0014 affected54 at risk
EG0021 affected7 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0008 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0008 affected70 at risk
EG0016 affected54 at risk
EG0020 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0007 affected70 at risk
EG00110 affected54 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0006 affected70 at risk
EG00113 affected54 at risk
EG0020 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0015 affected54 at risk
EG0020 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0016 affected54 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0008 affected70 at risk
EG0015 affected54 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0009 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG00010 affected70 at risk
EG00117 affected54 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0019 affected54 at risk
EG0020 affected7 at risk
EG003
Chest pain
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0007 affected70 at risk
EG0017 affected54 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MedDRA v13.0
Non-systematic Assessment
EG00019 affected70 at risk
EG00122 affected54 at risk
EG0021 affected7 at risk
EG003
Infusion related reaction
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Pain
General disorders
MedDRA v13.0
Non-systematic Assessment
EG00011 affected70 at risk
EG0016 affected54 at risk
EG0021 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA v13.0
Non-systematic Assessment
EG00010 affected70 at risk
EG00113 affected54 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG00012 affected70 at risk
EG00110 affected54 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG00011 affected70 at risk
EG00115 affected54 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0009 affected70 at risk
EG00120 affected54 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG00011 affected70 at risk
EG00111 affected54 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0016 affected54 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0007 affected70 at risk
EG0016 affected54 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0007 affected70 at risk
EG0018 affected54 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0015 affected54 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG00013 affected70 at risk
EG00112 affected54 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG00012 affected70 at risk
EG0019 affected54 at risk
EG0020 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0006 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0012 affected54 at risk
EG0021 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0006 affected70 at risk
EG0017 affected54 at risk
EG0021 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0013 affected54 at risk
EG0021 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0013 affected54 at risk
EG0021 affected7 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Haemoglobin
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0012 affected54 at risk
EG0022 affected7 at risk
EG003
Blood glucose increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Transaminases increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Gamma-glutamyltransferase
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Aspartate Aminotransferase
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Blood alkaline phosphatase
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Platelet count
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Alanine aminotransferase
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Blood creatinine
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Carbon dioxide decreased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Neutrophil count
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
White blood cell count
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Blood creatine phosphokinase
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Haematocrit
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Protein urine present
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Urine bilirubin increased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0016 affected54 at risk
EG0020 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Borrelia infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Furuncle
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Rash pustular
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Viral infection
Infections and infestations
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Haemoglobinaemia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Depression
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0015 affected54 at risk
EG0020 affected7 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Agitation
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Decreased activity
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Delirium
Psychiatric disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Hot flush
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0021 affected7 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0021 affected7 at risk
EG003
Vision blurred
Eye disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Visual impairment
Eye disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Diplopia
Eye disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Dry eye
Eye disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Pericardia effusion
Cardiac disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0013 affected54 at risk
EG0021 affected7 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Testicular torsion
Reproductive system and breast disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0021 affected7 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0011 affected54 at risk
EG0021 affected7 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0005 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0021 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0006 affected70 at risk
EG0014 affected54 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0003 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Oedema
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0004 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Chest discomfort
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0001 affected70 at risk
EG0012 affected54 at risk
EG0020 affected7 at risk
EG003
Ulcer
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hyperthermia
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0011 affected54 at risk
EG0020 affected7 at risk
EG003
Thirst
General disorders
MedDRA v13.0
Non-systematic Assessment
EG0000 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0010 affected54 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA v13.0
Non-systematic Assessment
EG0002 affected70 at risk
EG0013 affected54 at risk
EG0020 affected7 at risk
EG003
The study was closed to further enrollment due to a decision by the Sponsor to discontinue development of R1507. The decision was made based upon available data from other completed/ongoing trials of R1507 and was not due to safety concerns.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
F. Hoffmann-La Roche AG
+41 616878333
global.trial_information@roche.com
ID
Term
D012509
Sarcoma
Ancestor Terms
ID
Term
D018204
Neoplasms, Connective and Soft Tissue
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C558734
RG-1507 monoclonal antibody
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
23 subjects
FG00539 subjects
FG00618 subjects
FG00712 subjects
FG00810 subjects
FG0097 subjects
FG01012 subjects
FG0117 subjects
33.8
± 18.83
BG00441.7± 16.11
BG00526.5± 12.21
BG00631.7± 13.67
BG00723.1± 6.09
BG00860.9± 11.27
BG00926.9± 11.01
BG01050.6± 11.06
BG01130.7± 18.56
BG01231.2± 13.36
3
BG00320
BG00411
BG00518
BG00612
BG0071
BG0083
BG0092
BG0103
BG0113
BG012118
Male
BG00050
BG00132
BG0024
BG00320
BG00414
BG00523
BG00611
BG00713
BG0088
BG0097
BG0109
BG0118
BG012199
25
OG00441
OG00523
OG00614
OG00711
OG0089
OG00912
OG01011
4.88
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG00070
Title
Denominators
Categories
Title
Measurements
OG00015.81
Units
Counts
Participants
OG00070
OG00154
Title
Denominators
Categories
Title
Measurements
OG00096
OG00196
OG00070
Title
Denominators
Categories
Title
Measurements
OG0008.57
OG002
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG003
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG004
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG005
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG006
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG007
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG008
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG00054
OG0010
OG00240
OG00325
OG00441
OG00523
OG00614
OG00711
OG0089
OG00912
OG01011
Title
Denominators
Categories
Title
Measurements
OG00017.16
OG00219.69
OG0034.00
OG0047.32
OG00545.40
OG0068.16
OG00762.34
OG0080
OG0098.33
OG01022.86
OG003
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG004
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG005
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG006
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG007
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG008
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG009
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG0007
OG00140
OG00225
OG00341
OG00423
OG00514
OG00611
OG0079
OG00812
OG00911
Title
Denominators
Categories
Title
Measurements
OG00085.7
OG001100
OG002100
OG00395
OG00491
OG00586
OG006100
OG007100
OG008100
OG009100
Cohort 2: Ewings Sarcoma Secondary Cohort
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
OG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG00070
OG00154
OG0020
OG00340
OG00425
OG00541
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG00044.29(18 to NA)Upper limit was not reached due to low number of events.
OG00142.86(18.14 to NA)Upper limit was not reached due to low number of events.
OG003NA(30.14 to NA)DOR and upper limit were not reached due to low number of events.
OG00413.14(13.14 to NA)Upper limit was not reached due to low number of events.
OG005NA(21 to NA)DOR and upper limit were not reached due to low number of events.
OG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG00070
OG00154
OG0020
OG00340
OG00425
OG00541
OG00623
OG00714
OG00811
OG0099
OG01012
OG01111
Title
Denominators
Categories
Title
Measurements
OG0006.00(5.29 to 9.71)
OG0016.00(5.71 to 8.14)
OG0035.71(5.57 to 7.00)
OG0046.00(5.57 to 6.43)
OG0055.50(5.14 to 6.14)
OG00611.14(6.00 to 17.71)
OG0076.14(5.86 to 11.14)
OG00818.00(5.71 to NA)Upper limit was not reached due to low number of events.
OG0095.57(5.14 to 5.86)
OG0105.86(5.29 to 8.43)
OG0116.14(5.86 to 10.00)
OG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG00070
OG00154
OG0020
OG00340
OG00425
OG00561
OG00623
OG00714
OG00811
OG0099
OG01012
OG01111
Title
Denominators
Categories
Title
Measurements
OG00029.57(20.57 to 37.57)
OG00143.57(33.29 to 69.00)
OG00337.14(25.57 to NA)Upper limit was not reached due to low number of events.
OG00440.71(21.71 to 64.14)
OG00530.86(21.57 to 50.00)
OG00642.43(42.43 to NA)Upper limit was not reached due to low number of events.
OG00740.86(23.57 to NA)Upper limit was not reached due to low number of events.
OG008NA(NA to NA)All participants were censored as no deaths occurred.
OG00917.00(9.14 to NA)Upper limit was not reached due to low number of events.
OG01036.00(33.14 to NA)Upper limit was not reached due to low number of events.
OG01117.43(13.00 to 30.14)
OG002
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG00070
OG00154
OG0020
OG00340
OG00425
OG00541
OG00623
OG00714
OG00811
OG0099
OG01012
OG01111
Title
Denominators
Categories
Title
Measurements
OG0006.00(5.29 to 9.57)
OG0016.00(5.71 to 8.14)
OG0035.71(5.57 to 6.43)
OG0046.00(5.43 to 6.14)
OG0055.43(5.14 to 6.14)
OG00611.14(5.71 to 11.71)
OG0076.14(5.86 to 11.14)
OG00818.00(5.71 to NA)Upper limit was not reached due to low number of events.
OG0095.57(5.14 to 5.86)
OG0105.86(5.29 to 8.43)
OG0116.14(5.86 to 10)
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Cohort 3: Ewings Sarcoma Expanded Cohort
Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
OG003
Cohort 4: Osteosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
OG004
Cohort 5: Synovial Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
OG005
Cohort 6: Rhabdomyosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
OG006
Cohort 7a: Alveolar Soft Part Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.
OG007
Cohort 7b: Desmoplastic Small Round Cell Tumors.
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
OG008
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
OG009
Cohort 7d: Clear Cell Sarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
OG010
Cohort 7e: Myxoid Liposarcoma
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
OG011
Cohort 8: Diagnosis Not Specified
Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.