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Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

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NCT00976508

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Minneapolis, Minnesota, 55455 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Sarcoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00976508
Pfizer
Terminated
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

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Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of 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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Breast Neoplasms
  • Prostatic Neoplasms
  • Sarcoma
  • Drug: figitumumab
    IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
    Other Name: CP-751,871
  • Drug: pegvisomant
    growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
    Other Name: Somavert
Experimental: 1
Interventions:
  • Drug: figitumumab
  • Drug: pegvisomant
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
October 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Finland,   Germany,   United States
 
 
NCT00976508
A4021040
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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