This study is searching for participants with advanced solid tumors including breast cancer to examine the safety and effectiveness of experimental drug avapritinib (AYVAKIT). The main outcomes to be measured are the response to treatment and side effects. This trial is being conducted in Texas, US.
Some cancers grow as a response to genetic changes. CKIT or PDGFRA activating mutations are such changes. Tumors that are positive for these activating mutations are more likely to spread to nearby tissues (locally advanced) or other places in the body (metastatic). Avapritinib is a targeted therapy used for the treatment of tumors with specific rare mutations. It may stop the growth of tumor cells by blocking some proteins they need to grow.
This trial is evaluating the effectiveness of avapritinib for the treatment of solid tumors with CKIT or PDGFRA activating mutations. The main outcomes to be evaluated will be tumor response and side effects.
Who are they looking for?
The trial is looking to enroll 50 patients with solid advanced tumors including breast cancer. Participants must have CKIT or PDGFRA activating mutations and must have had disease worsening with standard therapy. Participants must have adequate blood cell counts, kidney, liver, and heart function and must have clearance of any side effects experienced from previous therapy before the trial. Females of childbearing potential must not get pregnant through 30 days after the last dose of study treatment. Men must abstain from sexual activity or use effective birth control for the course of study through 30 days after the last dose of study treatment. Participants must also agree to have a tissue sample (biopsy) taken.
Patients with unstable brain cancer are excluded except those with untreated and stable brain metastases. Patients with serious heart diseases are not able to participate in the trial. Other exclusion criteria include head injury or stroke, ulcer, stomach abnormalities, bone fracture, presence of other progressive diseases, history of seizures, and depression.
How will it work
There will be only one group in the trial. All the participants will be treated with avapritinib orally once daily on days 1-28. Cycles will repeat every 28 days depending on the state of disease or no issue with drug side effects.
Patients will be followed up at 30 days and then every 8 weeks up to 4 years to measure overall response and side effects to the treatment.