A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)

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Study Number:
20090505

Topic:
Glioblastoma

Principal Investigator:
Chaudhary

Ongoing:
Ongoing

Place:
Barrett Cancer Center; University Hospital; University Pointe

Overview:

This study will see if AMG 595 is safe when given to adult men and women and whether it causes any side effects.  This study will also look at what doses of  AMG 595 are safe for people to take and evaluate the amount of AMG 595 in your blood at various times during the study. The purpose of this study is to find out more about AMG 595 in people with cancer. AMG 595 is still experimental and is not approved by any regulatory health agency (like the Food and Drug Administration [FDA] or European Medicines Agency [EMA]) for use in people with cancer. It is anticipated that you will be in this study for about 7.5 months depending on how you are tolerating and responding to treatment with AMG 595.  This includes a 14-day screening period when tests and assessments will be done to determine if you can participate in this study, about 6 months of treatment and a follow up visit about 1 month after your last dose of AMG 595. When you have completed treatment, long-term follow up will continue approximately every 4 months until 12 months after the last person was enrolled in the study.   About twenty (20) people will take part in this research study at the University of Cincinnati.  Up to 60 subjects are expected to enroll in the study at various institutions.

Qualifications:
Qualified participants must be at least 18 and have recurrent malignant glioma (brain cancer).

Contact:
For more information, please contact Alison Kastl, BS, CCRC, Director of Clinical Trials, at kastla@ucmail.uc.edu or (513) 584-0436.

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