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

This study has been completed.
Sponsor:
Collaborator:
Sarcoma Alliance for Research through Collaboration
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642941
First received: March 19, 2008
Last updated: October 13, 2014
Last verified: October 2014

March 19, 2008
October 13, 2014
November 2007
June 2010   (final data collection date for primary outcome measure)
  • 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
Not Provided
Not Provided
 
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, rhabdomyos arcoma, and other sarcomas. All patients will receive R1507 9mg/kg i.v. weekly. The anticipated time on study treatment is until disease progression or unaccept able adverse events, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: RG1507
9mg/kg iv weekly
Experimental: 1
Intervention: Drug: RG1507

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
June 2010
June 2010   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom
 
NCT00642941
NO21157, SARC011
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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