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A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's Sarcoma That Has Relapsed After Standard Systemic Therapy

Phase 2
4 Years
Open (Enrolling)
Osteosarcoma, Sarcoma, Ewing's, Peripheral Neuroectodermal Tumor

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Trial Information

A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's Sarcoma That Has Relapsed After Standard Systemic Therapy

Participants with resectable osteosarcoma will be randomized to one of two dose levels of
SCH 717454 to be given intravenously. These participants will first receive SCH 717454
according to randomized treatment, and have surgery performed 10 to 14 days after initial
dosing. Participants will be allowed to recover from surgery four to six weeks prior to
additional SCH 717454 administration at their randomized dose level. SCH 717454 will then
be administered on the same calendar day once every two weeks. Participants will continue
to receive SCH 717454 until disease recurrence, or until completing a year of dosing at the
same dose level assigned, whichever occurs first.

Participants with unresectable osteosarcoma or Ewing´s sarcoma will be assigned treatment to
SCH 717454 IV administered once every two weeks and will continue to receive SCH 717454
until disease progression. Participants who achieve a CR or PR after tumor evaluations may
undergo surgical resection. After surgery, participants are eligible to receive 10 mg/kg
SCH717454 until disease recurrence/progression or one year of total dosing, whichever occurs

Inclusion Criteria:

- 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's 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's 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 Criteria:

- 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-IGF-1R targeted drug or antibody

- A participant with known hypersensitivity to other antibodies, or any accompanying
excipients associated with these medications.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

For participants with resectable osteosarcoma: change in tumor proliferation rate.

Outcome Time Frame:

approximately 14 days

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

August 2013

Related Keywords:

  • Osteosarcoma
  • Sarcoma, Ewing's
  • Peripheral Neuroectodermal Tumor
  • anti-IGF-1R
  • Osteosarcoma
  • Neuroectodermal Tumors
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma