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Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors


Phase 1
10 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Sarcoma

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Trial Information

Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of figitumumab plus pegvisomant in patients with advanced solid tumors

Outcome Time Frame:

4-Feb-2011

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021040

NCT ID:

NCT00976508

Start Date:

November 2009

Completion Date:

October 2012

Related Keywords:

  • Colorectal Neoplasms
  • Lung Neoplasms
  • Breast Neoplasms
  • Prostatic Neoplasms
  • Sarcoma
  • advanced solid tumors cancer refractory cancer figitumumab pegvisomant
  • Breast Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms
  • Sarcoma

Name

Location
Pfizer Investigational Site Rochester, Minnesota  55905