Overview

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