Terminated
PHASE2
INTERVENTIONAL
NCT00642941
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
RG1507
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
TimeFrame:
Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)
Description:
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.
Measure:
Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
TimeFrame:
Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)
Description:
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.
Measure:
Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
TimeFrame:
Baseline up to 6 years
Description:
Trial Information
NCT ID
NCT00642941
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Hoffmann-La Roche
Last Updated
December 15, 2025