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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.


Phase 2
2 Years
N/A
Open (Enrolling)
Both
Sarcoma

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

Week 24, and every 12 weeks thereafter

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21157

NCT ID:

NCT00642941

Start Date:

November 2007

Completion Date:

February 2014

Related Keywords:

  • Sarcoma
  • Sarcoma

Name

Location

Fountain Valley, California  92708
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Flint, Michigan  48532
Omaha, Nebraska  68114
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Washington, District of Columbia  
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814