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A Study of R1507 in Patients With Recurrent or Refractory Sarcoma.
This study is currently recruiting participants.
Study NCT00642941   Information provided by Hoffmann-La Roche
First Received: March 19, 2008   Last Updated: October 15, 2009   History of Changes

March 19, 2008
October 15, 2009
November 2007
 
  • Objective response rate [ Time Frame: Week 24, and every 12 weeks thereafter ] [ Designated as safety issue: No ]
  • Progression-free survival in patients with Ewing's sarcoma [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642941 on ClinicalTrials.gov Archive Site
  • Duration of response, PFS. [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
  • Overall PFS. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Overall objective response rate, response duration, overall PFS and overall survival in patients with Ewing's sarcoma. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
 
A Study of R1507 in Patients With Recurrent or Refractory Sarcoma.
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.

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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Sarcoma
Drug: R1507
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
180
April 2014
 

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.
Both
2 Years and older
No
Contact: Please reference Study ID Number: NO21157 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States,   Australia,   Canada,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom
 
NCT00642941
Disclosures Group, Hoffmann-La Roche
NO21157, SARC011
Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP