Study Stopped
The study was closed to further enrollment due to the decision by the Sponsor to discontinue development of R1507.
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.
3 other identifiers
interventional
317
11 countries
41
Brief Summary
The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2007
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2014
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedFebruary 3, 2021
January 1, 2021
6.2 years
March 19, 2008
September 9, 2020
January 14, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is \>=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)
Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response) at 18 weeks from start of treatment.
Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)
Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
Baseline up to 6 years
Secondary Outcomes (10)
Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8
Baseline, every 6 weeks until disease progression (up to 18 weeks)
Percentage of Participants With AEs in Cohorts 3-8
Baseline up to 6 years
Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8
Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)
- +5 more secondary outcomes
Study Arms (12)
Cohort 1: Ewings Sarcoma Primary Cohort
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Cohort 2: Ewings Sarcoma Secondary Cohort
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Cohort 3: Ewings Sarcoma Expanded Cohort
EXPERIMENTALParticipants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.
Cohort 4: Osteosarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.
Cohort 5: Synovial Sarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.
Cohort 6: Rhabdomyosarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.
Cohort 7a: Alveolar Soft Part Sarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a includes individuals with alveolar soft part sarcoma.
Cohort 7b: Desmoplastic Small Round Cell Tumors.
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.
Cohort 7c: Extraskeletal Myxoid Chondrosarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.
Cohort 7d: Clear Cell Sarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.
Cohort 7e: Myxoid Liposarcoma
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.
Cohort 8: Diagnosis Not Specified
EXPERIMENTALParticipants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Interventions
Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Eligibility Criteria
You may qualify if:
- 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;
- Cohort 3 only: age must be \>= 2 and \<= 21 years
You may not qualify if:
- clinically significant unrelated systemic illness which would compromise the participant'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;
- treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents;
- current or prior therapy with insulin-like growth factor (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;
- active central nervous system disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
City of Hope National Medical Center
Duarte, California, 91010, United States
UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology
Los Angeles, California, 90095-1752, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Stanford Comprehensive Cancer Center
Stanford, California, 94305, United States
Washington Cancer Institute; Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
NIH/NCI
Bethesda, Maryland, 20892, United States
Massachusetts General Hospital; Dana Farber Partnes Cancer Center
Boston, Massachusetts, 02114, United States
Dana Farber Partners Can Ctr
Boston, Massachusetts, 02115-6084, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Nebraska Methodist Hospital; Onc Hem West
Omaha, Nebraska, 68114, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Albert Einstein College of Medical Pediatrics; Department of Pediatrics
The Bronx, New York, 10467, United States
Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy
Charlotte, North Carolina, 28203, United States
Oregon Health and Science University Cancer Institute
Portland, Oregon, 97239, United States
Pennsylvania Oncology Hema Asc
Philadelphia, Pennsylvania, 19106, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Texas Children's Cancer Center; Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute; Orthopedic Center
Salt Lake City, Utah, 84112, United States
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, 3000, Australia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Institut Bergonie; Oncologie
Bordeaux, 33076, France
Centre Oscar Lambret; Chir Cancerologie General
Lille, 59000, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Institut Gustave Roussy; Service Pediatrique
Villejuif, 94805, France
HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III
Bad Saarow, 15526, Germany
Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie
Mannheim, 68167, Germany
University Hospital Tübingen
Tübingen, 72076, Germany
Istituti Ortopedici Rizzoli
Bologna, Emilia-Romagna, 40136, Italy
Istituto Nazionale Tumori, Sarcoma Unit
Milan, Lombardy, 20133, Italy
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
Rotterdam, 3015 CE, Netherlands
Norwegian Radium Hospital
Oslo, 0310, Norway
Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, 08950, Spain
Skånes University Hospital, Skånes Department of Onclology
Lund, 221 85, Sweden
UCL Hospital NHS Trust
London, NW1 2PG, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London, SW3 6JJ, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
Related Publications (2)
Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.
PMID: 22682017DERIVEDPappo AS, Patel SR, Crowley J, Reinke DK, Kuenkele KP, Chawla SP, Toner GC, Maki RG, Meyers PA, Chugh R, Ganjoo KN, Schuetze SM, Juergens H, Leahy MG, Geoerger B, Benjamin RS, Helman LJ, Baker LH. R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. J Clin Oncol. 2011 Dec 1;29(34):4541-7. doi: 10.1200/JCO.2010.34.0000. Epub 2011 Oct 24.
PMID: 22025149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was closed to further enrollment due to a decision by the Sponsor to discontinue development of R1507. The decision was made based upon available data from other completed/ongoing trials of R1507 and was not due to safety concerns.
Results Point of Contact
- Title
- Study Director
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
December 18, 2007
Primary Completion
February 19, 2014
Study Completion
February 19, 2014
Last Updated
February 3, 2021
Results First Posted
February 3, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).