NCT04267939

ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

An Open-label Phase 1b Study to Determine the Maximum Tolerated and/or Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib (BAY 1895344) in Combination With PARP Inhibitor Niraparib, in Participants With Recurrent Advanced Solid Tumors and Ovarian Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to test how well patients with advanced solid tumors and ovarian cancer respond to treatment with elimusertib in combination with niraparib. In addition researchers want to find for patients the optimal dose of elimusertib in combination with niraparib, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication elimusertib works by blocking a substance produced by the body (ATR Kinase) which is important for the growth of tumor cells. Niraparib works by blocking a substance produced by the body (PARP enzymes) in a way that tumor cells can be killed, or made more susceptible to chemotherapy.

Conditions

• Advanced Solid Tumors (Excluding Prostate Cancer)
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Elimusertib (BAY1895344)	Elimusertib will be administered in 28-day cycles.
DRUG	Niraparib	Niraparib will be administered in 28-day cycles.

Timeline

• Start date: 2020-02-26
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-02-13
• Last updated: 2023-12-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study