Study on APG-115 for Treating Salivary Gland Cancer
Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials ID:NCT03781986
This clinical trial is testing the effectiveness of a drug called APG-115, used alone, for treating salivary gland cancer that does not have a specific genetic mutation (p53 wild-type).
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the use of APG-115, a medication being tested for its ability to treat salivary gland cancer that cannot be cured with standard treatments. The trial is currently focusing on using APG-115 by itself, after an earlier phase that included a combination with another drug, Carboplatin, was stopped due to side effects.
Description
The trial is designed to test APG-115 as a single treatment for salivary gland cancer. Initially, the study included a combination of APG-115 with Carboplatin, but this was stopped early because of concerns about side effects. Now, the study continues with APG-115 alone, as approved by the relevant medical board in June 2021. The goal is to see if APG-115 can effectively treat this type of cancer on its own.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of malignant salivary gland cancer that cannot be cured with standard treatments, or have chosen not to undergo curative treatment.
- Have had genetic testing showing no p53 mutation.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable cancer that has grown by at least 20% in the past year, as shown by a CT scan.
- Have a life expectancy of at least 12 weeks.
- Be willing to sign an informed consent form and follow the study's schedule and procedures.
- Be able to take oral medication without altering the capsules.
- Have adequate organ and bone marrow function as shown by tests done within two weeks before joining the study.
Exclusion Criteria
- Have previously been treated with MDM2 inhibitors.
- Have received any cancer treatment, including chemotherapy or hormone therapy, for salivary gland cancer within four weeks before starting the study.
- Have received live vaccines or antiretroviral drugs within four weeks before starting the study.
- Have cancer that has progressed within six months after the last dose of platinum-based chemotherapy.
- Have active cancer that has spread to the brain, unless previously treated and stable.
- Have a serious uncontrolled medical condition or active infection that would interfere with the study treatment.
- Are of childbearing potential and not willing or able to use two methods of contraception or practice abstinence during the study and for 90 days after the last dose.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Michigan Rogel Cancer Center | 48109 | Ann Arbor | Michigan |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.