A New Targeted Therapy CX‑5461 to Treat Advanced Breast, Ovarian, Pancreatic or Prostate Cancer with an ATM, BRCA1/2, CHEK2, PALB2 or Other Mutation
https://www.facingourrisk.org/research-clinical-trials/study/377/an-new-targeted-therapy-cx5461-to-treat-advanced-breast-ovarian-pancreatic-or-prostate-cancer-with-inherited-or-tumor-mutations
Clinicaltrials.gov identifier:
NCT04890613 (https://clinicaltrials.gov/show/NCT04890613)
Treatment
Phase 1 treatment study for advanced or metastatic breast, ovarian, pancreatic or prostate cancer
Study Contact Information:
Name: Serena Robinson
📞 Phone: 1-858-552-6808
📧 Email: [email protected]
Name: Hylee Lee
📞 Phone: 1-858-552-6808
📧 Email: [email protected]
You may also contact the study sites for additional information.
About the Study
This research study is testing the safety and effectiveness of an investigational targeted therapy called CX‑5461. CX-5461 is a type of drug known as a POL-I inhibitor. It works by preventing tumors from repairing DNA damage.
The goal is to find a safe dose and learn more about how well the drug works to treat advanced breast, ovarian, pancreatic or prostate cancers in people with certain inherited or tumor‑related gene mutations, including including ATM, BARD1, BRCA1, BRCA2, BRIP1, CHEK2, NBN, PALB2, RAD51C, RAD51D or other mutations related to DNA repair.
What the Study Involves
All participants will receive the study drug, CX‑5461 through an IV (into a vein)
- Treatment is given on Day 1 and Day 8 of a 28‑day cycle
- Participants will continue treatment as long as the cancer does not worsen and side effects are manageable
- Participants will have regular follow up, which includes:
- Physical exams
- Blood tests
- Scans to check the cancer
- Questionnaires about quality of life
Blood tests will be collected over the course of the study to help researchers understand how the cancer changes over time, look for signs that the cancer may be becoming resistant to treatment and see how well the treatment is working.
This Study is Open To:
Participants with all of the following may be eligible to participate:
- Advanced breast, ovarian, pancreatic or prostate cancer.
- An inherited or tumor mutation in one of the following genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CHEK2, NBN, PALB2, RAD51C, RAD51D or other mutations related to DNA repair.
- Must have measurable disease.
- Must undergo biopsy at time of progression if safe.
- Must have adequate heart, kidney, liver, and bone marrow function.
- Any infections (such as HIV or hepatitis) must be treated and under control.
There is no minimum or maximum number of lines of prior therapy and prior PARP inhibitor therapy is allowed.
This Study is Not Open To:
Patients may not be eligible if they have any of the following:
- Unmanaged brain metastasis.
- Another disease or condition that is not stable or under control.
- Unresolved serious side effects from previous treatments.
- Are receiving other systemic medications for their cancer.
- Certain conditions of the eye.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.