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ATR Inhibitor Plus Niraparib Study in Advanced Solid Tumors and Ovarian Cancer

ATR Inhibitor Plus Niraparib Study in Advanced Solid Tumors and Ovarian Cancer

Clinicaltrials.gov identifier:
NCT04267939

Treatment:
Ovarian, Breast, Pancreatic

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 well people with advanced ovarian, fallopian tube or primary peritoneal cancer or other solid tumors respond to treatment with the targeted therapy BAY1895344 in combination with the PARP inhibitor niraparib. This study is open to participants who have had their ovarian cancer progress while on a PARP inhibitor

Type of Study

This is an open-label, 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 solid tumors and a tumor mutation in a DNA damage repair gene (DDR). This may include BRCA1, BRCA2 and ATM
  • Group B1: Participants with ovarian, fallopian tube or primary peritoneal cancer who have not previously received a PARP inhibitor, have platinum-resistant disease not responding to treatment, and have a tumor mutation in a DNA Damage Repair (DDR) gene. This may include BRCA1, BRCA2, ATM and other genes.  
  • Group B2: Participants with ovarian, fallopian tube or primary peritoneal cancer and have disease progression while on a PARP inhibitor.

All study participants will receive the following:

  • BAY1895344 (a type of targeted therapy known as an ATR inhibitor) will be administered twice per day in a 28 day-cycle.
  • Niraparib (a PARP inhibitor) 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

This Study is Open To:

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 solid tumors (excluding prostate cancer) with disease progression after treatment with standard therapies for metastatic cancer.
    • Part B: Patients with recurrent ovarian, fallopian tube or primary peritoneal cancer
      • Part B Sub-population 1: Patients who have not previously received a PARP inhibitor and with platinum-resistant disease not responding to treatment.
      • Part B Sub-population 2: Patients with disease progression on a PARP inhibitor.
  • Participants in Part A and Part B Sub-population
    • will need to have DNA Damage Repair (DDR) gene mutation in their tumors (such as a mutation in one of the following genes:  ATM, BRCA1, BRCA2 and other genes. If you have an inherited or tumor mutation in another gene, contact the study coordinator to see if you qualify. 

 

This Study is Not Open To:

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 PARP inhibitor treatment due to severe adverse effects