Trial information

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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study

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 Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: July, 2008

Trial registration date: 03/18/2008

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Australia

• Melbourne
• Sydney
• Westmead

Canada

• Vancouver, BC

France

• Bordeaux
• Lille
• Lyon
• Marseille
• Paris
• Villejuif

Germany

• Bad Saarow
• Frankfurt Am Main
• Mannheim
• Munster
• Tübingen

Italy

• Bologna
• Milano

Netherlands

• Rotterdam

Norway

• Oslo

Spain

• Barcelona
• Madrid
• Palma de Mallorca

Sweden

• Lund
• Stockholm

United Kingdom

• Birmingham
• London
• Manchester

United States

• Little Rock, AR
• Duarte, CA
• Los Angeles, CA
• Santa Monica, CA
• Stanford, CA
• West Hollywood, CA
• Washington, DC
• Gainesville, FL
• Tampa, FL
• Atlanta, GA
• Coeur D'Alene, ID
• Baltimore, MD
• Bethesda, MD
• Boston, MA
• Ann Arbor, MI
• Rochester, MN
• Omaha, NE
• Bronx, NY
• New York, NY
• Charlotte, NC
• Portland, OR
• Philadelphia, PA
• Nashville, TN
• Houston, TX
• Salt Lake City, UT
• Seattle, WA