ATR Inhibitor Plus Niraparib Study in Advanced Solid Tumors and Ovarian Cancer
Clinicaltrials.gov identifier:
NCT04267939
Treatment
Advanced ovarian cancer or other solid tumors
Study Contact Information:
For additional information, contact: Bayer Clinical Trials by phone: 1-888-842-2937 or by email
ATR Inhibitor BAY 1895344 Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer
About the Study
This study will look at how well how people with advanced ovarian, or primary peritoneal cancer or other respond to treatment with the BAY1895344 in combination with the niraparib. This study is open to participants who have had their ovarian cancer progress while on a .
Type of Study
This is an , single group study. All participants will receive the same medications.
What the Study Entails
Study participants will be placed into one of three groups based on their situation.
- Group A: Participants with advanced and a tumor mutation in a damage repair gene (DDR). This may include , and .
- Group B1: Participants with ovarian, or primary peritoneal cancer who have not previously received a , have platinum-resistant disease not responding to treatment, and have a tumor mutation in a Damage Repair (DDR) gene. This may include , , and other genes.
- Group B2: Participants with ovarian, or primary peritoneal cancer and have disease progression while on a .
All study participants will receive the following:
- BAY1895344 (a type of known as an ATR inhibitor) will be administered twice per day in a 28 day-cycle.
- (a ) will be administered orally once daily continuously throughout the cycle.
Study participants will be followed for up to 24 months.
Study Sites
Massachusetts
Boston, MA
Dana-Farber Cancer Institute
New York
New York, NY
Memorial Sloan-Kettering Cancer Center
Ohio
Cleveland
Cleveland Clinic
Texas
Houston
MD Anderson Cancer Center
People age 18 years and older can be considered for enrollment in this study if they:
- Meet either Part A or Part B criteria defined as follows:
- Part A: Patients with advanced (excluding cancer) with disease progression after treatment with standard therapies for cancer.
- Part B: Patients with recurrent ovarian, or primary peritoneal cancer
- Part B Sub-population 1: Patients who have not previously received a and with platinum-resistant disease not responding to treatment.
- Part B Sub-population 2: Patients with disease progression on a .
- Participants in Part A and Part B Sub-population
- will need to have Damage Repair (DDR) gene mutation in their tumors (such as a mutation in one of the following genes: , , and other genes. If you have an inherited or tumor mutation in another gene, contact the study coordinator to see if you qualify.
People cannot participate if they have any of the following:
- History of HIV infection
- Active Hepatitis B or Hepatitis C
- History of cardiac disease
- Immunocompromised patients
- Had previous treatment with an ATR Inhibitor
- Discontinued previous treatment due to severe adverse effects