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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, November 2009
First Received: March 19, 2008   Last Updated: November 17, 2009   History of Changes
Sponsor: Hoffmann-La Roche
Collaborator: 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

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.

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 ] [ 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: 180
Study Start Date: November 2007
Estimated Study Completion Date: July 2014
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 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, California
Recruiting
Santa Monica, California, United States, 90403
Recruiting
Stanford, California, United States, 94305
Recruiting
Duarte, California, United States, 91010
Not yet recruiting
West Hollywood, California, United States, 90048
Not yet recruiting
Los Angeles, California, United States, 90095
Recruiting
Los Angeles, California, United States, 90095-1752
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20010-2931
United States, Florida
Not yet recruiting
Gainesville, Florida, United States, 32610
Not yet recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Not yet recruiting
Atlanta, Georgia, United States, 30308
United States, Idaho
Recruiting
Coeur D'alene, Idaho, United States, 83814
United States, Maryland
Recruiting
Bethesda, Maryland, United States, 20892-1926
Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 01225-6084
Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States, 48109-0848
United States, Minnesota
Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
Recruiting
Omaha, Nebraska, United States, 68114
United States, New Jersey
Recruiting
Charlotte, New Jersey, United States, 28203
United States, New York
Recruiting
New York, New York, United States, 10021
Recruiting
Bronx, New York, United States, 10467
Recruiting
New York, New York, United States, 10065
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19106
Recruiting
Philadelphia, Pennsylvania, United States, 19111-2412
United States, Tennessee
Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Recruiting
Houston, Texas, United States, 77030
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84108
United States, Washington
Not yet recruiting
Seattle, Washington, United States, 98105
Australia
Not yet recruiting
Westmead, Australia, 2145
Recruiting
Melbourne, Australia, 3002
Not yet recruiting
Sydney, Australia, 2050
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
France
Recruiting
Lyon, France, 69008
Not yet recruiting
Marseille, France, 13005
Not yet recruiting
Villejuif, France, 94805
Recruiting
Lille, France, 59000
Recruiting
Bordeaux, France, 33076
Recruiting
Villejuif, France, 94805
Recruiting
Paris, France, 75248
Germany
Not yet recruiting
Frankfurt Am Main, Germany, 60325
Not yet recruiting
Mannheim, Germany, 68167
Recruiting
Mannheim, Germany, 68167
Recruiting
Münster, Germany, 481249
Recruiting
Tübingen, Germany, 72076
Recruiting
Bad Saarow, Germany, 15526
Italy
Recruiting
Bologna, Italy, 40136
Recruiting
Milano, Italy, 20133
Netherlands
Recruiting
Rotterdam, Netherlands, 3075 AE
Norway
Recruiting
Oslo, Norway, 0310
Spain
Not yet recruiting
Barcelona, Spain, 08025
Not yet recruiting
Barcelona, Spain, 08907
Recruiting
Barcelona, Spain, 08950
Not yet recruiting
Palma de Mallorca, Spain, 07014
Not yet recruiting
Madrid, Spain, 28041
Sweden
Recruiting
Lund, Sweden, 22185
Not yet recruiting
Stockholm, Sweden, 76
United Kingdom
Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Recruiting
London, United Kingdom, NW1 2PG
Recruiting
London, United Kingdom, SW3 6JJ
Not yet recruiting
Birmingham, United Kingdom, B4 6NH
Active, not recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers: NO21157, SARC011
Study First Received: March 19, 2008
Last Updated: November 17, 2009
ClinicalTrials.gov Identifier: NCT00642941     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2009