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A Study of R1507 in Patients With Recurrent or Refractory Sarcoma.
This study is currently recruiting participants.
Verified by Hoffmann-La Roche, April 2009
First Received: March 19, 2008   Last Updated: April 21, 2009   History of Changes
Sponsors and Collaborators: Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642941
  Purpose

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
Sarcoma
Drug: R1507
Phase II

MedlinePlus related topics: Soft Tissue Sarcoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55
Study Start Date: July 2008
Estimated Study Completion Date: November 2013
Arms Assigned Interventions
1: Experimental Drug: R1507
9mg/kg iv weekly

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642941

Contacts
Contact: Please reference Study ID Number: NO21157 973-235-5000
Contact: or 800-526-6367 (FOR US ONLY)

  Show 63 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Investigators
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers: NO21157, SARC011
Study First Received: March 19, 2008
Last Updated: April 21, 2009
ClinicalTrials.gov Identifier: NCT00642941     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Osteosarcoma
Ewing's Sarcoma
Insulin
Recurrence
Antibodies, Monoclonal
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Antibodies
Sarcoma, Ewing's
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Sarcoma
Mitogens
Osteogenic Sarcoma
Synovial Sarcoma
Ewing's Family of Tumors
Immunoglobulins
Rhabdomyosarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Sarcoma

ClinicalTrials.gov processed this record on May 07, 2009