This trial is aiming to examine the effectiveness of an experimental drug, AMXI-5001, in patients with advanced breast cancer. The main outcomes that are to be measured in this trial are side effects and the response to treatment. This trial is going to be carried out in California, Tennessee, and Florida, the United States.
In patients with advanced cancers, current treatments are of limited effectiveness. Therefore, new treatments are necessary. AMXI-5001 is a dual PARP (a protein involved in cellular functions) and microtubule (structural component of cells) inhibitor. This means that it slows down the spread of cancerous cells. It is an experimental treatment that has shown good anti-tumor activity in experimental studies.
This trial is being carried out to determine if AMXI-5001 could potentially be used to treat advanced cancers that have spread and are no longer responsive to current treatment options. The main outcomes that are to be measured are drug side effects and the response to treatment.
Who are they looking for?
This trial is looking to recruit 80 patients with advanced cancers, including breast cancer. To be included in this trial patients must have confirmed advanced breast cancer that is no longer responding to existing treatment options or has progressed with current standard treatments.
Patients will be excluded from this trial if they are receiving cancer treatment at the enrollment time, have another illness affecting a major organ system, or significant heart and vascular disease. Patients with another type of cancer will also be excluded.
How will it work
There will be one treatment arm in this trial. All patients will be assigned AMXI-5001 tablets. This will be administered twice a day for 4 consecutive days during one week.
Side effects and tumor response will be measured up to 24 months.