Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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