A Study to Determine the Activity of SCH 717454 in Subjects With Relapsed Osteosarcoma or Ewing's Sarcoma (Study P04720AM3) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00617890

Purpose

Subjects 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 subjects 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. Subjects with unresectable osteosarcoma or Ewing´s sarcoma will receive SCH 717454 IV once every two weeks until disease progression.

Condition	Intervention	Phase
Osteosarcoma Sarcoma, Ewing's Peripheral Neuroectodermal Tumor	Drug: SCH 717454 (19D12)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's Sarcoma That Has Relapsed After Standard Systemic Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	190
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental SCH 717454 IV dose A once every 2 weeks.	Drug: SCH 717454 (19D12) SCH 717454 will be administered intravenously once every two weeks until disease progression.
Arm B: Experimental SCH 717454 IV dose B once every 2 weeks.	Drug: SCH 717454 (19D12) SCH 717454 will be administered intravenously once every two weeks until disease progression.

Detailed Description:

Subjects with resectable osteosarcoma will be randomized to one of two dose levels of SCH 717454 to be given intravenously. These subjects will first receive SCH 717454 according to randomized treatment, and have surgery performed at a defined time after initial dosing. Subjects will be allowed to recover from surgery prior to additional SCH 717454 administration at their randomized dose level. SCH 717454 will then be administered on the same calendar day once every 2 weeks.

Subjects 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. Subjects 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.

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A subject must be 11 years of age or older and may be of any race, and gender; subjects between 4 and 10 years of age, inclusive, may be considered on a site-by-site basis.
A subject must have a diagnosis of histologically confirmed osteosarcoma or Ewing's sarcoma;
A subject 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 subject >16 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2; a subject <=16 years of age must have a Karnofsky performance status between 50% and 100% or a Lansky play scale between 50% and 100%;
A subject must have adequate organ function.

Exclusion Criteria:

A subject 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 subject who has known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion;
A subject with a history of uncontrolled diabetes mellitus;
A subject with a recent myocardial infarction (within the past year); or a subject 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 subject with an active infection;
A subject with clinically significant hepatitis at Screening, or a subject that is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive;
A subject who has been treated with an anti-IGF-1R targeted drug or antibody;
A subject with known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617890

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Show 58 Study Locations

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04720
Study First Received:	January 17, 2008
Last Updated:	August 16, 2009
ClinicalTrials.gov Identifier:	NCT00617890 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

anti-IGF-1R

Study placed in the following topic categories:

Neuroectodermal Tumors, Primitive
Osteosarcoma
Ewing's Sarcoma
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas

Neoplasms, Germ Cell and Embryonal
Peripheral Neuroectodermal Tumor
Sarcoma
Neuroepithelioma
Osteogenic Sarcoma
Ewing's Family of Tumors
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Nerve Tissue
Osteosarcoma
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Neoplasms

Neoplasms, Bone Tissue
Neoplasms, Germ Cell and Embryonal
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009