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R1507 (teprotumumab) in recurrent/refractory sarcomas
NCT00642941Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2007
- Primary completion
- Feb 2014
- Countries
- 11
- Sponsor
- Roche
- Modality
- Monoclonal Antibodies
- Drugs
- teprotumumab
- Conditions
- Ewing sarcomaosteosarcoma (OS)synovial sarcoma (SS)rhabdomyosarcoma (RMS)alveolar soft part sarcoma (ASPS)
01
Overview
Phase 2, open-label trial of teprotumumab in Ewing sarcoma, osteosarcoma (OS), synovial sarcoma (SS) and 6 more (12 arms), sponsored by Roche. Primary endpoints: Objective Response Rate up to 6 years, Progression-Free Survival Rate at 18 weeks and 1 more. Started Dec 2007; status: terminated.
02
Design
12 arms- Study design
- Non-randomizedOpen-label
Ewings Sarcoma Primary
R1507 9 mg/kg weekly
Ewings Sarcoma Secondary
R1507 9 mg/kg weekly
Ewings Sarcoma Expanded
R1507 27 mg/kg every 3 weeks
Osteosarcoma
R1507 9 mg/kg weekly
Synovial Sarcoma
R1507 9 mg/kg weekly
Rhabdomyosarcoma
R1507 9 mg/kg weekly
6 more in the full profile.
03
Who it enrols
Patients 2 years and older with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other specified sarcomas. Must have received prior chemotherapy (specifics vary by cohort). Excludes patients with CNS disease, prior IGF inhibitor therapy, or recent immunosuppressive treatment.
04
Endpoints
Primary
Objective Response Rate
Progression-Free Survival Rate
Adverse Events
Secondary
Objective Response Rate
Progression-Free Survival Rate
Duration of Response
Time to Progression
Failure-Free Survival
Overall Survival
Progression-Free Survival
Area Under the Concentration-Time Curve
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