A Study to Determine the Safety and Tolerability of the Experimental Drug PF-06840003 in Patients with Glioma

What we are studying

The purpose of this research study is to learn about the effects of the study drug, PF-06840003, and to find the best dose for treating patients with cancer PF-068400003 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country. PF-06840003 is a type of therapy called an IDO1 inhibitor. Indoleamine-pyrrole 2,3 dioxygenase, or IDO1, is an enzyme that is encoded by the IDO1 gene. It has been shown that IDO1 allows tumor cells to escape from your immune system which allows the tumor cells to remain in your body and grow. The study will see if PF-06840003 is able to change the ways that your tumor cells escape from your immune system. This study will attempt to answer the following questions: • What is the optimal dose of PF-06840003 in patients with gliomas? • What side effects occur when PF-06840003 is given? • How serious are the side effects and how long do they last? • How long after PF-06840003 is taken does it remain in your body? (This type of research is called pharmacokinetics). • Is the treatment with PF-06840003 effective in shrinking tumors?

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Cannot be pregnant or breastfeeding
  • Must agree to use two highly effective contraception methods if childbearing potential or able to father a child
  • Willing and able to comply to the protocol and all procedures in the study
  • Cannot have a life expectancy of less than 3 months
  • Cannot actively have an infection
  • Cannot currently use or anticipate to use products with tobacco in it
  • Cannot have mental condition

What is involved

  • Medical history review
  • Physical examination
  • Height
  • Weight
  • Vital signs
  • Performance status
  • Blood draw
  • Pregnancy test (blood or urine)
  • ECG (electrocardiogram)
  • ECHO (echocardiogram)
  • MRI (magnetic resonance imaging
  • PET scan
  • Questionnaires
  • Neurological assessment
  • Cognitive assessment

Compensation

None

Contact Information

Study Coordinator
Jill Pfefferkorn, RN
Email
[email protected]
Phone
-3539
Principal Investigator
Glenn Lesser, MD

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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.