AzTrials
AzTrials

SarcomaPhase 2NCT00642941

A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

A Phase 2 study testing RG1507 in people with Sarcoma, run by Hoffmann-La Roche at 41 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Sarcoma
What is being tested?
RG1507
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
41 sitesin 11 countries
Study dates
18 Dec 2007to 19 Feb 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

41 sites in 11 countries.

41 sites in 11 countries

United States22 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • NIH/NCI

    Bethesda, Maryland, 20892

  • Massachusetts General Hospital; Dana Farber Partnes Cancer Center

    Boston, Massachusetts, 02114

  • Dana Farber Partners Can Ctr

    Boston, Massachusetts, 02115-6084

  • Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy

    Charlotte, North Carolina, 28203

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Texas Children's Cancer Center; Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

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

    Los Angeles, California, 90095-1752

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Nebraska Methodist Hospital; Onc Hem West

    Omaha, Nebraska, 68114

  • Pennsylvania Oncology Hema Asc

    Philadelphia, Pennsylvania, 19106

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Oregon Health and Science University Cancer Institute

    Portland, Oregon, 97239

  • Huntsman Cancer Institute; Orthopedic Center

    Salt Lake City, Utah, 84112

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Stanford Comprehensive Cancer Center

    Stanford, California, 94305

  • Albert Einstein College of Medical Pediatrics; Department of Pediatrics

    The Bronx, New York, 10467

  • Washington Cancer Institute; Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

France5 sites

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Centre Oscar Lambret; Chir Cancerologie General

    Lille, 59000

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Institut Gustave Roussy; Service Pediatrique

    Villejuif, 94805

Other trials in France

Germany3 sites

  • HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III

    Bad Saarow, 15526

  • Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie

    Mannheim, 68167

  • University Hospital Tübingen

    Tübingen, 72076

Other trials in Germany

United Kingdom3 sites

  • UCL Hospital NHS Trust

    London, NW1 2PG

  • Royal Marsden Hospital; Dept of Med-Onc

    London, SW3 6JJ

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Italy2 sites

  • Istituti Ortopedici Rizzoli

    Bologna, Emilia-Romagna, 40136

  • Istituto Nazionale Tumori, Sarcoma Unit

    Milan, Lombardy, 20133

Other trials in Italy

Australia1 site

  • Peter Maccallum Cancer Institute; Medical Oncology

    Melbourne, Victoria, 3000

Other trials in Australia

Canada1 site

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Netherlands1 site

  • Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

    Rotterdam, 3015 CE

Other trials in Netherlands

Norway1 site

  • Norwegian Radium Hospital

    Oslo, 0310

Other trials in Norway

Spain1 site

  • Hospital Sant Joan De Deu

    Esplugues de Llobregas, Barcelona, 08950

Other trials in Spain

Sweden1 site

  • Skånes University Hospital, Skånes Department of Onclology

    Lund, 221 85

Other trials in Sweden

About this study

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.

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.

Conditions
Sarcoma
Being tested
RG1507
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RG1507Drug

    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.

Study groups in NCT00642941
Study groupRoleWhat they receive
Cohort 1: Ewings Sarcoma Primary CohortExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 2: Ewings Sarcoma Secondary CohortExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 3: Ewings Sarcoma Expanded CohortExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 4: OsteosarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 5: Synovial SarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 6: RhabdomyosarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 7a: Alveolar Soft Part SarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
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.
Receives: Drug: RG1507
Cohort 7c: Extraskeletal Myxoid ChondrosarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 7d: Clear Cell SarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 7e: Myxoid LiposarcomaExperimentalParticipants 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.
Receives: Drug: RG1507
Cohort 8: Diagnosis Not SpecifiedExperimentalParticipants 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.
Receives: Drug: RG1507

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

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

    Measured: Baseline up to 6 years

Secondary outcomes (10)

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

    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.

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

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

    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.

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

  3. Percentage of Participants With AEs in Cohorts 3-8

    Measured: Baseline up to 6 years

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: Baseline until death (up to 6 years)

  8. 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.

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

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

    Measured: 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)

  10. Pharmacokinetics: Clearance (CL) of R1507

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2008 (estimated)
  2. Study start18 Dec 2007
  3. Primary completion19 Feb 2014
  4. Study completion19 Feb 2014

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00642941
Sponsor's protocol ID
NO21157
Other IDs
SARC011, 2007-003940-30
Status last verified
Jan 2021
First submitted
19 Mar 2008
Last updated
3 Feb 2021
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 22682017

  • 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.

    PubMed 22025149

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RG1507 in people with Sarcoma, run by Hoffmann-La Roche at 41 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, France, Germany, United Kingdom, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 (time frame: Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00642941, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in