Trial Information

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

Status: Recruiting

Protocol Number: NO21157

Sponsor: Hoffmann-La Roche; SARC

Company Division: Pharmaceutical

Official Scientific 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.

Brief Summary: 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. Target sample size is 305.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Sarcoma

Intervention Type: Drug

Intervention Name: R1507

Primary Outcome: 1. Objective response rate Time frame: Week 24, and every 12 weeks thereafter 2. Progression-free survival in patients with Ewing's sarcoma Time frame: Week 18

Key Secondary Outcomes: 1. Duration of response, PFS. Time frame: Week 18 2. Overall PFS. Time frame: Event driven 3. Overall objective response rate, response duration, overall PFS and overall survival in patients with Ewing's sarcoma. Time frame: Event driven

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.

Gender: Males or Females

Age Limits: Min: 2 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2008

Trial Registration Date: 03/18/2008

Date Last Updated: 10/23/2008

Link To Trial Results

Contact:

Research Site:
Located in:
Houston, TX 77030
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: December 2, 2008 at 3:14:04 PM


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