Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Prostatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Dose escalation will initiate with Part A.1 in which niraparib is used at a lower fixed dose.

If the starting dose level in Part A.1 is tolerated, dose escalation in Part A.2 may be initiated on an optional basis. In Part A.2, niraparib is used at a higher fixed dose.

MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose.

MTD: Maximum tolerated dose. RP2D: Recommended phase 2 dose.

MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose.

MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.

Elimusertib will be administered in 28-day cycles.

Elimusertib (BAY1895344)

Niraparib will be administered in 28-day cycles.

Bayer Study Director

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.

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

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

GlaxoSmithKline

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer	NCT04267939	Advanced Solid ... Ovarian Cancer	Elimusertib (BA... Niraparib	18 Years -	Bayer
ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer	NCT04267939	Advanced Solid ... Ovarian Cancer	Elimusertib (BA... Niraparib	18 Years -	Bayer
ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer	NCT04267939	Advanced Solid ... Ovarian Cancer	Elimusertib (BA... Niraparib	18 Years -	Bayer

Spots Global Cancer Trial Database for advanced solid tumors (excluding prostate cancer)