Phase I Trial of AZD7451, A Topomysin-Receptor Kinase (TRK) Inhibitor, For Adults With Recurrent Glioblastoma Multiforme (GBM)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- To establish the maximum tolerated dose of AZD7451 on a continuous once daily schedule in patients with recurrent gliomas not on enzyme-inducing anti-epileptic drugs (EIAED).
Study Overview
Brief Summary
Background:
- AZD7451 is a drug that may help interfere with brain tumor cell growth. It can prevent glioma cells from entering into normal brain tissue, and slow or stop the growth of additional tumors. Researchers want to see if AZD7451 is effective against gliomas that have not responded to surgery, radiation, or chemotherapy.
Objectives:
- To see if AZD7451 is a safe and effective treatment for gliomas that have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have gliomas that have not responded to standard treatments.
Design:
- Participants will be screened with a physical exam, medical history, blood and urine tests, heart function tests, an eye exam, and imaging studies.
- Participants will take AZD7451 daily by mouth for 28-day cycles of treatment.
- Participants will keep a medication diary and record any side effects. Treatment will be monitored with frequent blood tests and imaging studies.
- Treatment will continue as long as there are no serious side effects and the tumor does not start growing again....
Detailed Description
BACKGROUND:
Recurrent glioma patients have very limited treatment options. A major cause of gliomarelated morbidity and mortality is the extensive infiltrative and invasive nature of glioma cells. Thus, inhibition of glioma invasion is a potentially promising strategy.
Work in the Neuro-Oncology Branch laboratory of Dr. Howard Fine has identified TrkA as an important signaling receptor for mediating glioma cell invasion. Both genetic and pharmacological inhibition of Trk potently inhibits glioma invasion and tumor progression in vitro and in vivo. AZD7451 is a first in-class inhibitor of Trk.
OBJECTIVES:
To establish the maximally tolerated dose (MTD) of continuous twice a day AZD7451 dosing in patients with recurrent glioblastoma not on enzyme-inducing anti-epileptic drugs (EIAED).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To establish the maximum tolerated dose of AZD7451 on a continuous once daily schedule in patients with recurrent gliomas not on enzyme-inducing anti-epileptic drugs (EIAED).
Time Frame: 3 years
Secondary Outcomes
- To obain exploratory information about the anti-tumor activity of AZD7451.(3 years)