Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
NCT ID: NCT00976508
Last Updated: 2013-12-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2009-11-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
pegvisomant
growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
figitumumab
IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
Interventions
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pegvisomant
growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
figitumumab
IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients between the ages of 10 and 18 years with advanced sarcomas for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life will be included in the Sarcoma Expansion Cohort.
* Adequate recovery from prior therapies.
* Adequate organ function (i.e. bone marrow, kidney, liver)
* Total IGF-1 ≥100 ng/ml (13 nmol/L).
Exclusion Criteria
* Pregnant or breastfeeding females.
* Significant past history or active cardiac disease
* Active infection
* History of diabetes mellitus.
* Glycosylated hemoglobin \>5.7
10 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Helsinki, , Finland
Pfizer Investigational Site
Münster, , Germany
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4021040
Identifier Type: -
Identifier Source: org_study_id