Status:
TERMINATED
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Sarcoma Alliance for Research through Collaboration
Conditions:
Sarcoma
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2014
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00642941
Start Date
December 18 2007
End Date
February 19 2014
Last Update
February 3 2021
Active Locations (41)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology
Los Angeles, California, United States, 90095-1752
3
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
4
Stanford Comprehensive Cancer Center
Stanford, California, United States, 94305