Status:
TERMINATED
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Colorectal Neoplasms
Lung Neoplasms
Eligibility:
All Genders
10+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
Detailed Description
This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.
Eligibility Criteria
Inclusion
- Patients ≥18 years of age with advanced solid tumors for which the combination of figitumumab and pegvisomant are reasonable treatment options.
- 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
- Concurrent treatment with any anti-tumor agents.
- Pregnant or breastfeeding females.
- Significant past history or active cardiac disease
- Active infection
- History of diabetes mellitus.
- Glycosylated hemoglobin \>5.7
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00976508
Start Date
November 1 2009
End Date
October 1 2012
Last Update
December 13 2013
Active Locations (5)
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1
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
2
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
3
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
4
Pfizer Investigational Site
Helsinki, Finland, 00290