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A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Primary Purpose

Sarcoma

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RG1507

About this trial

This is an interventional treatment trial for Sarcoma

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

City of Hope National Medical Center
UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology
Sarcoma Oncology Center
Stanford Comprehensive Cancer Center
Washington Cancer Institute; Washington Hospital Center
Kootenai Medical Center
Johns Hopkins Hospital
NIH/NCI
Massachusetts General Hospital; Dana Farber Partnes Cancer Center
Dana Farber Partners Can Ctr
University of Michigan Comprehensive Cancer Center
Nebraska Methodist Hospital; Onc Hem West
Albert Einstein College of Medical Pediatrics; Department of Pediatrics
Memorial Sloan Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy
Oregon Health and Science University Cancer Institute
Pennsylvania Oncology Hema Asc
Fox Chase Cancer Center
Texas Children's Cancer Center; Baylor College of Medicine
University of Texas M.D. Anderson Cancer Center
Huntsman Cancer Institute; Orthopedic Center
Peter Maccallum Cancer Institute; Medical Oncology
BCCA-Vancouver Cancer Centre
Institut Bergonie; Oncologie
Centre Oscar Lambret; Chir Cancerologie General
Centre Leon Berard; Departement Oncologie Medicale
Institut Curie; Oncologie Medicale
Institut Gustave Roussy; Service Pediatrique
HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III
Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie
University Hospital Tübingen
Istituti Ortopedici Rizzoli
Istituto Nazionale Tumori, Sarcoma Unit
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
Norwegian Radium Hospital
Hospital Sant Joan De Deu
Skånes University Hospital, Skånes Department of Onclology
UCL Hospital NHS Trust
Royal Marsden Hospital; Dept of Med-Onc
Christie Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Arm Label

Cohort 1: Ewings Sarcoma Primary Cohort

Cohort 2: Ewings Sarcoma Secondary Cohort

Cohort 3: Ewings Sarcoma Expanded Cohort

Cohort 4: Osteosarcoma

Cohort 5: Synovial Sarcoma

Cohort 6: Rhabdomyosarcoma

Cohort 7a: Alveolar Soft Part Sarcoma

Cohort 7b: Desmoplastic Small Round Cell Tumors.

Cohort 7c: Extraskeletal Myxoid Chondrosarcoma

Cohort 7d: Clear Cell Sarcoma

Cohort 7e: Myxoid Liposarcoma

Cohort 8: Diagnosis Not Specified

Arm Description

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

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.

Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2

Secondary Outcome Measures

Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1

PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8

Percentage of Participants With AEs in Cohorts 3-8

Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. 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.

Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8

TTP is defined as the time from date of randomization until objective tumor progression. According to the WHO Response Criteria, objective tumor progression is > 25% increase in the area of one or more measurable lesions or the appearance of new lesions.

Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8

FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.

Overall Survival (OS) in Cohorts 1 to 8

OS was measured from the time of study registration to the date of death or was censored at the date of last contact.

PFS According to WHO Response Criteria in Cohorts 1 to 8

PFS is defined as the duration of time from start of treatment to time of objective progression or death.

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507

Pharmacokinetics: Clearance (CL) of R1507

Full Information

NCT ID

NCT00642941

First Posted

March 19, 2008

Last Updated

January 14, 2021

Sponsor

Hoffmann-La Roche

Collaborators

Sarcoma Alliance for Research through Collaboration

1. Study Identification

Unique Protocol Identification Number

NCT00642941

Brief Title

A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was closed to further enrollment due to the decision by the Sponsor to discontinue development of R1507.

Study Start Date

December 18, 2007 (Actual)

Primary Completion Date

February 19, 2014 (Actual)

Study Completion Date

February 19, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

Collaborators

Sarcoma Alliance for Research through Collaboration

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

317 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Ewings Sarcoma Primary Cohort

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2: Ewings Sarcoma Secondary Cohort

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Cohort 3: Ewings Sarcoma Expanded Cohort

Arm Type

Experimental

Arm Description

Arm Title

Cohort 4: Osteosarcoma

Arm Type

Experimental

Arm Description

Arm Title

Cohort 5: Synovial Sarcoma

Arm Type

Experimental

Arm Description

Arm Title

Cohort 6: Rhabdomyosarcoma

Arm Type

Experimental

Arm Description

Arm Title

Cohort 7a: Alveolar Soft Part Sarcoma

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Cohort 7b: Desmoplastic Small Round Cell Tumors.

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Cohort 7c: Extraskeletal Myxoid Chondrosarcoma

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Cohort 7d: Clear Cell Sarcoma

Arm Type

Experimental

Arm Description

Arm Title

Cohort 7e: Myxoid Liposarcoma

Arm Type

Experimental

Arm Description

Arm Title

Cohort 8: Diagnosis Not Specified

Arm Type

Experimental

Arm Description

Participants 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.

Intervention Type

Drug

Intervention Name(s)

RG1507

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8

Description

Time Frame

Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)

Title

Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1

Description

Time Frame

Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)

Title

Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2

Time Frame

Baseline up to 6 years

Secondary Outcome Measure Information:

Title

Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1

Description

Time Frame

Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Title

PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8

Description

Time Frame

Baseline, every 6 weeks until disease progression (up to 18 weeks)

Title

Percentage of Participants With AEs in Cohorts 3-8

Time Frame

Baseline up to 6 years

Title

Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8

Description

Time Frame

Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Title

Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8

Description

Time Frame

Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Title

Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8

Description

FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.

Time Frame

Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Title

Overall Survival (OS) in Cohorts 1 to 8

Description

OS was measured from the time of study registration to the date of death or was censored at the date of last contact.

Time Frame

Baseline until death (up to 6 years)

Title

PFS According to WHO Response Criteria in Cohorts 1 to 8

Description

PFS is defined as the duration of time from start of treatment to time of objective progression or death.

Time Frame

Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Title

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507

Time Frame

Predose (0 hours [h]), end of 60-90 minutes infusion (EOI), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)

Title

Pharmacokinetics: Clearance (CL) of R1507

Time Frame

Predose (0 h), EOI (infusion over 60-90 minutes), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope National Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1752

Country

United States

Facility Name

Sarcoma Oncology Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

Facility Name

Stanford Comprehensive Cancer Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Washington Cancer Institute; Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Kootenai Medical Center

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

NIH/NCI

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Facility Name

Massachusetts General Hospital; Dana Farber Partnes Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana Farber Partners Can Ctr

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115-6084

Country

United States

Facility Name

University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Nebraska Methodist Hospital; Onc Hem West

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Albert Einstein College of Medical Pediatrics; Department of Pediatrics

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Oregon Health and Science University Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Pennsylvania Oncology Hema Asc

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Texas Children's Cancer Center; Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Texas M.D. Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Huntsman Cancer Institute; Orthopedic Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Peter Maccallum Cancer Institute; Medical Oncology

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

BCCA-Vancouver Cancer Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Institut Bergonie; Oncologie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Centre Oscar Lambret; Chir Cancerologie General

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Centre Leon Berard; Departement Oncologie Medicale

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Institut Curie; Oncologie Medicale

City

Paris

ZIP/Postal Code

75231

Country

France

Facility Name

Institut Gustave Roussy; Service Pediatrique

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

University Hospital Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Istituti Ortopedici Rizzoli

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40136

Country

Italy

Facility Name

Istituto Nazionale Tumori, Sarcoma Unit

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Norwegian Radium Hospital

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

Hospital Sant Joan De Deu

City

Esplugues De Llobregas

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

Skånes University Hospital, Skånes Department of Onclology

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

UCL Hospital NHS Trust

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Royal Marsden Hospital; Dept of Med-Onc

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Christie Hospital NHS Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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).

Citations:

PubMed Identifier

22682017

Citation

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.

Results Reference

derived

PubMed Identifier

22025149

Citation

Pappo 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.

Results Reference

derived

Learn more about this trial

A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

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