A Study to Determine the Activity of SCH 717454 in Subjects With Relapsed Osteosarcoma or Ewing's Sarcoma (Study P04720AM5)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00617890

First received: January 17, 2008

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 17, 2008
Last Updated Date	June 13, 2012
Start Date ^ICMJE	February 2008
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 22, 2012)	For participants with resectable osteosarcoma: change in tumor proliferation rate. [ Time Frame: approximately 14 days ] [ Designated as safety issue: No ] For participants with relapsed and unresectable osteosarcoma or Ewing's sarcoma: tumor response rate. [ Time Frame: until disease progression or one year of dosing ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: February 6, 2008)	For subjects with resectable osteosarcoma: change in tumor proliferation rate. [ Time Frame: approximately 14 days ] [ Designated as safety issue: No ] For subjects with unresectable osteosarcoma or Ewing's sarcoma: tumor response rate. [ Time Frame: until disease progression ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00617890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 13, 2012)	For participants with resectable osteosarcoma: time to relapse. [ Time Frame: Until disease progression or one year of dosing. ] [ Designated as safety issue: No ] Pharmacokinetic data [ Time Frame: Evaluation up to eighth dose. ] [ Designated as safety issue: No ] Pharmacodynamic properties will be assessed. [ Time Frame: Throughout the study. ] [ Designated as safety issue: No ] Safety [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ] For participants with resectable osteosarcoma: overall survival. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] For participants with relapsed and unresectable osteosarcoma or Ewing's sarcoma: duration of response [ Time Frame: until disease progression or one year of dosing ] [ Designated as safety issue: No ] For participants with relapsed and unresectable osteosarcoma or Ewing's sarcoma: time to progression [ Time Frame: until disease progression or one year of dosing ] [ Designated as safety issue: No ] For participants with relapsed and unresectable osteosarcoma or Ewing's sarcoma: overall survival. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: February 6, 2008)	For subjects with resectable osteosarcoma: Time to progression. [ Time Frame: Until disease progression or one year of dosing. ] [ Designated as safety issue: No ] Pharmacokinetic data [ Time Frame: Evaluation up to eighth dose. ] [ Designated as safety issue: No ] Pharmacodynamic parameters will be assessed. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] Safety [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Determine the Activity of SCH 717454 in Subjects With Relapsed Osteosarcoma or Ewing's Sarcoma (Study P04720AM5)
Official Title ^ICMJE	A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's Sarcoma That Has Relapsed After Standard Systemic Therapy
Brief Summary	Participants with relapsed osteosarcoma that can be treated with surgery will be randomized to SCH 717454 administered intravenously (IV) at one of two dose levels. These participants will first receive SCH 717454, have surgery performed, and continue to receive treatment every two weeks until a year of dosing, or until disease progression. Participants with unresectable osteosarcoma or Ewing´s sarcoma will receive SCH 717454 IV once every two weeks until disease progression. Participants who achieve a complete response (CR) or partial response (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 first.
Detailed Description	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 first.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Osteosarcoma Sarcoma, Ewing's Peripheral Neuroectodermal Tumor
Intervention ^ICMJE	Drug: SCH 717454 (19D12) SCH 717454 will be administered intravenously once every two weeks until disease progression. Other Name: SCH 717454
Study Arm (s)	Experimental: SCH 717454 0.3 mg SCH 717454 IV 0.3 mg/kg once every 2 weeks. Intervention: Drug: SCH 717454 (19D12) Experimental: SCH 717454 10 mg SCH 717454 IV 10 mg/kg once every 2 weeks. Intervention: Drug: SCH 717454 (19D12)
Publications *	Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	249
Estimated Completion Date	August 2013
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	4 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00617890
Other Study ID Numbers ^ICMJE	P04720
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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