Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Lung Neoplasms; Sarcoma; Prostatic Neoplasms; Breast Neoplasms; Colorectal Neoplasms

Treatments: Drug: pegvisomant; Drug: figitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00976508

A4021040

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

1

Experimental group

Treatment:

Drug: figitumumab

Drug: pegvisomant