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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00642941
Registration number
NCT00642941
Ethics application status
Date submitted
19/03/2008
Date registered
25/03/2008
Titles & IDs
Public title
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
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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.
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Secondary ID [1]
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SARC011
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Secondary ID [2]
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NO21157
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)
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Primary outcome [2]
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Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)
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Primary outcome [3]
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Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
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Assessment method [3]
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Timepoint [3]
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Baseline up to 6 years
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Secondary outcome [1]
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Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
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Secondary outcome [2]
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PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, every 6 weeks until disease progression (up to 18 weeks)
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Secondary outcome [3]
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Percentage of Participants With AEs in Cohorts 3-8
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Assessment method [3]
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Timepoint [3]
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Baseline up to 6 years
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Secondary outcome [4]
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Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
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Secondary outcome [5]
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Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
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Secondary outcome [6]
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Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8
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Assessment method [6]
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FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.
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Timepoint [6]
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Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
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Secondary outcome [7]
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Overall Survival (OS) in Cohorts 1 to 8
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Assessment method [7]
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OS was measured from the time of study registration to the date of death or was censored at the date of last contact.
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Timepoint [7]
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Baseline until death (up to 6 years)
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Secondary outcome [8]
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PFS According to WHO Response Criteria in Cohorts 1 to 8
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Assessment method [8]
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PFS is defined as the duration of time from start of treatment to time of objective progression or death.
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Timepoint [8]
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Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
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Secondary outcome [9]
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Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507
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Assessment method [9]
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Timepoint [9]
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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)
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Secondary outcome [10]
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Pharmacokinetics: Clearance (CL) of R1507
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Assessment method [10]
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Timepoint [10]
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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)
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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
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Minimum age
2
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/02/2014
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Sample size
Target
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Accrual to date
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Final
317
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Idaho
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Nebraska
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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Texas
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United States of America
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Utah
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Canada
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British Columbia
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France
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Bordeaux
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France
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Lille
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France
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Lyon
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France
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Paris
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France
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Villejuif
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Germany
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Bad Saarow
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Germany
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Mannheim
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Germany
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Tübingen
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Netherlands
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Rotterdam
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Norway
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Oslo
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Spain
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Barcelona
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Sweden
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Lund
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United Kingdom
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London
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United Kingdom
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State/province [30]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Sarcoma Alliance for Research through Collaboration
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00642941
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Trial related presentations / publications
Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7. 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.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00642941