Roche trials database

Trial information

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

Status:

Active, not recruiting

Protocol number:

NO21157

Sponsor:

Hoffmann-La Roche

Co-sponsors:

• 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 228.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• Sarcoma

Intervention type:

Drug

Intervention name:

RG1507

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:

November, 2007

Trial registration date:

20.12.2007

Date last updated:

06.05.2013

This trial was conducted at the following locations:

Australia

• MELBOURNE

Canada

• VANCOUVER, BC

France

• BORDEAUX
• LILLE
• LYON
• VILLEJUIF

FRANCE

• Paris

Germany

• BAD SAAROW
• MANNHEIM
• MÜNSTER
• TÜBINGEN

Italy

• BOLOGNA
• MILANO

Netherlands

• ROTTERDAM

Norway

• OSLO

Spain

• BARCELONA

Sweden

• LUND

U.S.A.

• DUARTE, CA
• LOS ANGELES, CA
• SANTA MONICA, CA
• STANFORD, CA
• COEUR D'ALENE, ID
• BOSTON, MA
• BALTIMORE, MD
• BETHESDA, MD
• ANN ARBOR, MI
• OMAHA, NE
• CHARLOTTE, NJ
• BRONX, NY
• NEW YORK, NY
• PORTLAND, OR
• PHILADELPHIA, PA
• HOUSTON, TX
• SALT LAKE CITY, UT

United Kingdom

• LONDON

UNITED KINGDOM

• MANCHESTER

UNITED STATES

• Washington, DC
• Philadelphia, PA
• HOUSTON, TX

Link to trial result