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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00617890
First received: January 17, 2008
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Osteosarcoma
Sarcoma, Ewing's
Peripheral Neuroectodermal Tumor
Drug: SCH 717454 (19D12)
Phase 2

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


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 219
Study Start Date: February 2008
Study Completion Date: August 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 717454 0.3 mg
SCH 717454 IV 0.3 mg/kg once every 2 weeks.
Drug: SCH 717454 (19D12)
SCH 717454 will be administered intravenously once every two weeks until disease progression.
Other Name: SCH 717454
Experimental: SCH 717454 10 mg
SCH 717454 IV 10 mg/kg once every 2 weeks.
Drug: SCH 717454 (19D12)
SCH 717454 will be administered intravenously once every two weeks until disease progression.
Other Name: SCH 717454

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.

  Eligibility

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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00617890     History of Changes
Other Study ID Numbers: P04720
Study First Received: January 17, 2008
Last Updated: September 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
anti-IGF-1R

Additional relevant MeSH terms:
Osteosarcoma
Neuroectodermal Tumors
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on April 17, 2014