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Trial record 1 of 1 for:    NCT00642941
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A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642941
First Posted: March 25, 2008
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sarcoma Alliance for Research through Collaboration
Information provided by (Responsible Party):
Hoffmann-La Roche
March 19, 2008
March 25, 2008
April 4, 2017
December 18, 2007
February 19, 2014   (Final data collection date for 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) ]
  • Progression-Free Survival (PFS) According to WHO Response Criteria at 18 weeks from Start of R2607 Treatment in Cohort 1 [ Time Frame: 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 [ Time Frame: Baseline up to 6 years ]
  • Objective response rate [ Time Frame: Week 24, and every 12 weeks thereafter ]
  • Progression-free survival in patients with Ewing's sarcoma [ Time Frame: Week 18 ]
Complete list of historical versions of study NCT00642941 on ClinicalTrials.gov Archive Site
  • Duration of Response (DOR) According to WHO Response Criteria in Cohorts 2 to 8 [ Time Frame: 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 2 to 8 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 2 to 8 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • Overall Survival (OS) in Cohorts 2 to 8 [ Time Frame: Baseline until death (up to 6 years) ]
  • PFS According to WHO Response Criteria at 18 Weeks from Start of R1507 Treatment in Cohorts 2 to 8 [ Time Frame: Baseline, every 6 weeks until disease progression (up to 18 weeks) ]
  • PFS According to WHO Response Criteria in Cohorts 2 to 8 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • Percentage of Participants with Complete or Partial Response According to WHO Response Criteria in Cohort 1 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • TTP According to WHO Response Criteria in Cohort 1 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • FFS According to WHO Response Criteria in Cohort 1 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • DOR According to WHO Response Criteria in Cohort 1 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • PFS According to WHO Response Criteria in Cohort 1 [ Time Frame: Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) ]
  • OS in Cohort 1 [ Time Frame: Baseline until death (up to 6 years) ]
  • Percentage of participants with AEs in all Cohorts [ Time Frame: Baseline up to 6 years ]
  • 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) ]
  • 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) ]
  • Duration of response, PFS. [ Time Frame: Week 18 ]
  • Overall PFS. [ Time Frame: Event driven ]
  • Overall objective response rate, response duration, overall PFS and overall survival in patients with Ewing's sarcoma. [ Time Frame: Event driven ]
Not Provided
Not Provided
 
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.
This study will evaluate the efficacy and safety of R1507 in participants with recurrent or refractory sarcoma. Eight cohorts of sarcoma participants will be studied in parallel. Cohort 1: Ewing's sarcoma primary cohort defined as participants who have relapsed less than or equal to (<=) 24 months from diagnosis, received at least two prior chemotherapy programs and are unresectable. Cohort 2: Ewing's sarcoma non-primary (secondary) cohort defined as participants who have relapsed greater than or equal to (>=) 24 months from diagnosis or have only received one prior chemotherapy program. Cohort 3: Expanded Ewing's sarcoma defined as participants with recurrent or relapse regardless of prior number of salvage regimens and regardless of time of relapse. Cohort 4: participants with osteosarcoma. Cohort 5: Participants with synovial sarcoma. Cohort 6: Participants with rhabdomyosarcoma Cohort 7: Participants with alveolar soft part sarcoma (7a), desmoplastic small round cell tumors (7b), extraskeletal myxoid chondrosarcoma (7c), clear cell sarcoma (7d), myxoid liposarcoma (7e). Cohort 8: Participants with unspecified sarcoma diagnosis. Participants in the expanded Ewing's sarcoma Cohort 3 will receive 27 milligrams (mg)/kilogram (kg) every 3 weeks intravenously (IV). All other participants will receive R1507 9 mg/kg IV weekly. The anticipated time on study treatment is until disease progression or unacceptable adverse events, withdrawal or death.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma
Drug: RG1507
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.
  • Experimental: Cohort 1: Ewing's Sarcoma Primary Cohort
    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.
    Intervention: Drug: RG1507
  • Experimental: Cohort 2: Ewing's Sarcoma Secondary Cohort
    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.
    Intervention: Drug: RG1507
  • Experimental: Cohort 3: Ewing's Sarcoma Expanded Cohort
    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.
    Intervention: Drug: RG1507
  • Experimental: Cohort 4: Osteosarcoma
    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 4 includes individuals with osteosarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 5: Synovial 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 5 includes individuals with synovial sarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 6: Rhabdomyosarcoma
    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 6 includes individuals with rhabdomyosarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 7a: 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 7a includes individuals with alveolar soft part sarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 7b: 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 7b includes individuals with desmoplastic small round cell tumors.
    Intervention: Drug: RG1507
  • Experimental: Cohort 7c: 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 7c includes individuals with extraskeletal myxoid chondrosarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 7d: Clear Cell 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 7d includes individuals with clear cell sarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 7e: Myxoid Liposarcoma
    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 7e includes individuals with myxoid liposarcoma.
    Intervention: Drug: RG1507
  • Experimental: Cohort 8: Diagnosis Not Specified
    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: Drug: RG1507

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
February 19, 2014
February 19, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Finland
 
NCT00642941
NO21157
SARC011
2007-003940-30 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP