Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00642941
Registration number
NCT00642941
Ethics application status
Date submitted
19/03/2008
Date registered
25/03/2008
Date last updated
3/02/2021
Titles & IDs
Public title
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
Query!
Scientific 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.
Query!
Secondary ID [1]
0
0
SARC011
Query!
Secondary ID [2]
0
0
NO21157
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sarcoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Sarcoma (also see 'Bone') - soft tissue
Query!
Cancer
0
0
0
0
Query!
Bone
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - RG1507
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: Cohort 7a: Alveolar Soft Part 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 7a includes individuals with alveolar soft part sarcoma.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Treatment: Drugs: RG1507
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)
Query!
Primary outcome [2]
0
0
Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)
Query!
Primary outcome [3]
0
0
Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline up to 6 years
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Query!
Secondary outcome [2]
0
0
PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline, every 6 weeks until disease progression (up to 18 weeks)
Query!
Secondary outcome [3]
0
0
Percentage of Participants With AEs in Cohorts 3-8
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline up to 6 years
Query!
Secondary outcome [4]
0
0
Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Query!
Secondary outcome [5]
0
0
Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Query!
Secondary outcome [6]
0
0
Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8
Query!
Assessment method [6]
0
0
FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.
Query!
Timepoint [6]
0
0
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Query!
Secondary outcome [7]
0
0
Overall Survival (OS) in Cohorts 1 to 8
Query!
Assessment method [7]
0
0
OS was measured from the time of study registration to the date of death or was censored at the date of last contact.
Query!
Timepoint [7]
0
0
Baseline until death (up to 6 years)
Query!
Secondary outcome [8]
0
0
PFS According to WHO Response Criteria in Cohorts 1 to 8
Query!
Assessment method [8]
0
0
PFS is defined as the duration of time from start of treatment to time of objective progression or death.
Query!
Timepoint [8]
0
0
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Query!
Secondary outcome [9]
0
0
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
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)
Query!
Secondary outcome [10]
0
0
Pharmacokinetics: Clearance (CL) of R1507
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
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)
Query!
Eligibility
Key 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
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/12/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/02/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
317
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Idaho
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Maryland
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Utah
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
British Columbia
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bordeaux
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Lille
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Lyon
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Paris
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Villejuif
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Bad Saarow
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Mannheim
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Tübingen
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Emilia-Romagna
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Lombardia
Query!
Country [25]
0
0
Netherlands
Query!
State/province [25]
0
0
Rotterdam
Query!
Country [26]
0
0
Norway
Query!
State/province [26]
0
0
Oslo
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Barcelona
Query!
Country [28]
0
0
Sweden
Query!
State/province [28]
0
0
Lund
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
London
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Sarcoma Alliance for Research through Collaboration
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00642941
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00642941
Download to PDF