Status:
TERMINATED
A Study to Determine the Activity of Robatumumab (SCH 717454) in Participants With Relapsed Osteosarcoma or Ewing's Sarcoma (MK-7454-002/P04720)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteosarcoma
Sarcoma, Ewing's
Eligibility:
All Genders
4+ years
Phase:
PHASE2
Brief Summary
Participants with relapsed osteosarcoma that can be treated with surgery will be randomized to robatumumab administered intravenously (IV) at one of two dose levels. These participants will first rece...
Detailed Description
Participants with resectable osteosarcoma will be randomized to one of two dose levels of robatumumab to be given intravenously. These participants will first receive robatumumab according to randomiz...
Eligibility Criteria
Inclusion
- A participant must be 11 years of age or older and may be of any race, and gender; participants between 4 and 10 years of age, inclusive, may be considered on a site-by-site basis.
- A participant must have a diagnosis of histologically confirmed osteosarcoma or Ewing sarcoma;
- A participant with either:
- relapsed and resectable osteosarcoma
- relapsed and unresectable osteosarcoma that is refractory to standard therapy, ie. has relapsed after prior systemic treatment with active chemotherapy agents
- Ewing sarcoma that is refractory to standard systemic therapies
- A participant \>16 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of \<=2; a participant \<=16 years of age must have a Karnofsky performance status between 50% and 100% or a Lansky play scale between 50% and 100%
- A participant must have adequate organ function.
Exclusion
- A participant with a history of another malignancy (with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix treated with curative intent at least 2 years prior to start of treatment, or other adequately treated malignancy for which the subject has been disease free for \>=5 years)
- A participant who has known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion
- A participant with a history of uncontrolled diabetes mellitus
- A participant with a recent myocardial infarction (within the past year); or a participant who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality
- A participant with an active infection
- A participant with clinically significant hepatitis at Screening, or a participant who is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive
- A participant who has been treated with an anti-insulin-like growth factor receptor 1 (anti-IGF-1R)- targeted drug or antibody
- A participant with known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2013
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00617890
Start Date
February 1 2008
End Date
August 31 2013
Last Update
August 23 2018
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