ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer
NCT04267939 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2023-12-21
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
- DRUG
-
Elimusertib (BAY1895344)
Elimusertib will be administered in 28-day cycles.
- DRUG
-
Niraparib
Niraparib will be administered in 28-day cycles.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-26
- Primary Completion
- 2023-12-01
- Completion
- 2023-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
NCT01154426 ·Status: COMPLETED ·Phase: PHASE1
-
M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer
NCT03579472 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
NCT01783444 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)
NCT04123366 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Combination of Olaparib and Navitoclax in Women with HGSC and TNBC
NCT05358639 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
NCT07318324 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
NCT01482156 ·Status: COMPLETED ·Phase: PHASE1
-
Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy
NCT00892736 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
NCT03742349 ·Status: TERMINATED ·Phase: PHASE1
-
A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Advanced Solid Tumors (MK-8628-006)
NCT02698176 ·Status: TERMINATED ·Phase: PHASE1
-
Combination Study of Prexasertib and Olaparib in Patients With Advanced Solid Tumors
NCT03057145 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study of Everolimus Beyond Progression
NCT02269670 ·Status: TERMINATED ·Phase: PHASE2
-
Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial
NCT05564416 ·Status: WITHDRAWN ·Phase: PHASE2
-
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
NCT06177171 ·Status: RECRUITING ·Phase: PHASE1
-
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer
NCT05826015 ·Status: WITHDRAWN ·Phase: PHASE1
-
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT05768139 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
NCT00426556 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
NCT00878709 ·Status: COMPLETED ·Phase: PHASE3
-
Bevacizumab in Multiple Phase I Combinations
NCT00543504 ·Status: COMPLETED ·Phase: PHASE1
-
Study of M4344 in Combination With Niraparib
NCT04655183 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Mirdametinib + BGB-3245 in Advanced Solid Tumors
NCT05580770 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer
NCT02318901 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
NCT05827614 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
NCT02807844 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors
NCT07156253 ·Status: RECRUITING ·Phase: PHASE1