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A Study of R1507 in Patients With Recurrent or Refractory Sarcoma.

This study has been completed.
Sarcoma Alliance for Research through Collaboration
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: March 19, 2008
Last updated: November 2, 2016
Last verified: November 2016
This single arm study will evaluate the efficacy and safety of R1507 in patients with recurrent or refractory sarcoma. Five cohorts of sarcoma patients will be studied in parallel: Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma, and other sarcomas. All patients will receive R1507 9mg/kg i.v. weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Drug: RG1507
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Patients With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Week 24, and every 12 weeks thereafter ]
  • Progression-free survival in patients with Ewing's sarcoma [ Time Frame: Week 18 ]

Secondary Outcome Measures:
  • Duration of response, PFS. [ Time Frame: Week 18 ]
  • Overall PFS. [ Time Frame: Event driven ]
  • Overall objective response rate, response duration, overall PFS and overall survival in patients with Ewing's sarcoma. [ Time Frame: Event driven ]

Enrollment: 228
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
9mg/kg iv weekly


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients >=2 years of age;
  • 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.

Exclusion Criteria:

  • clinically significant unrelated systemic illness which would compromise the patient'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;
  • current or previous treatment (within last 6 months) with chronic pharmacological doses of corticosteroids, immunosuppressive agents or medications that inactivate or may interfere with the pharmacological activity of R1507;
  • current or prior therapy with 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00642941

  Show 41 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Study Director: Clinical Trials Hoffmann-La Roche