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A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

NCT00642941

TerminatedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Sarcoma

Interventions: RG1507

Countries: United States, Australia, Canada, France, Germany, Italy, Netherlands, Norway

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.

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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

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
Locations (41)
  • Duarte, California, United States
  • Los Angeles, California, United States
  • Santa Monica, California, United States
  • Stanford, California, United States
  • Washington D.C., District of Columbia, United States
  • Coeur d'Alene, Idaho, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Charlotte, North Carolina, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Melbourne, Victoria, Australia
  • Vancouver, British Columbia, Canada
  • Bordeaux, France
  • Lille, France
  • Lyon, France
  • Paris, France
  • Villejuif, France
  • Bad Saarow, Germany
  • + 11 more on CT.gov