Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

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NCT00976508

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Study Location
Pfizer Investigational Site
Minneapolis, Minnesota, 55455, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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

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Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, SarcomaFigitumumab Combined With Pegvisomant For Advanced Solid Tumors
NCT00976508
  1. Minneapolis, Minnesota
  2. Rochester, Minnesota
  3. Montreal, Quebec
  4. Helsinki,
  5. Muenster,
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
Official Title  ICMJE Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors
Brief Summary This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Breast Neoplasms
  • Prostatic Neoplasms
  • Sarcoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: figitumumab
  • Drug: pegvisomant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 14, 2011)		24
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2009)		42
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Finland,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976508
Other Study ID Numbers  ICMJE A4021040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP