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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
317
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.
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.
Time frame: 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.
Time frame: 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
Time frame: Baseline up to 6 years
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.
Time frame: 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
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City of Hope National Medical Center
Duarte, California, United States
UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology
Los Angeles, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Stanford Comprehensive Cancer Center
Stanford, California, United States
Washington Cancer Institute; Washington Hospital Center
Washington D.C., District of Columbia, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
NIH/NCI
Bethesda, Maryland, United States
Massachusetts General Hospital; Dana Farber Partnes Cancer Center
Boston, Massachusetts, United States
Dana Farber Partners Can Ctr
Boston, Massachusetts, United States
...and 31 more locations
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.
Time frame: Baseline, every 6 weeks until disease progression (up to 18 weeks)
Percentage of Participants With AEs in Cohorts 3-8
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)