Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colorectal Neoplasms Lung Neoplasms Breast Neoplasms Prostatic Neoplasms Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

pegvisomant

Intervention Type DRUG

growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year

figitumumab

Intervention Type DRUG

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

Intervention Type DRUG

figitumumab

IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year

Intervention Type DRUG

Other Intervention Names

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CP-751,871 Somavert

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No