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ATR Inhibitor

Elimusertib + Niraparib for Ovarian Cancer

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with cycle 3, and at the start of every 4th cycle after cycle 11 up to 24 months.
Awards & highlights

Summary

This trial is testing the effect of a new drug, elimusertib, when used in combination with niraparib, on patients with advanced solid tumors or ovarian cancer. The goal is to find the optimal dose of elimusertib to use in combination with niraparib, and to see how well the drug combination works and is tolerated.

Eligible Conditions
  • Ovarian Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with cycle 3, and at the start of every 4th cycle after cycle 11 up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with cycle 3, and at the start of every 4th cycle after cycle 11 up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment emergent adverse events (TEAEs)
Incidence of treatment emergent serious adverse events (TESAEs)
Maximum tolerated dose (MTD): Frequency of Dose Limiting Toxicities (DLTs) at each dose level during the DLT observation period for Cycle 1
+3 more
Secondary outcome measures
AUC(0-8) of elimusertib after single dose administration
AUC(0-8)md of elimusertib after multiple dose administration
Cmax (Maximal plasma exposure) of elimusertib after single dose administration
+7 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Vomiting
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Back pain
9%
Alanine aminotransferase increased
9%
Blood bilirubin increased
9%
Non-cardiac chest pain
9%
Anxiety
9%
Dry mouth
9%
Cough
9%
Urinary tract infection
9%
Hypertension
9%
Dehydration
4%
Hyperkalemia
4%
Head injury
4%
Bloating
4%
Unknown infection
4%
Hyponatremia
4%
Syncope
4%
Ascites
4%
Hoarseness
4%
Upper respiratory infection
4%
Lung infection
4%
Tremor
4%
White blood cell decreased
4%
Hypotension
4%
Sinus pain
4%
Diarrhea
4%
Esophageal ulcer
4%
Hypokalemia
4%
Skin tear
4%
Sore throat
4%
Leukocytosis
4%
Flu like symptoms
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Bruising
4%
Postnasal drip
4%
Hematuria
4%
Depression
4%
Edema limbs
4%
Hot flashes
4%
Oral petechia
4%
Hyperglycemia
4%
Itchy eyes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose expansion_sub-population 2_lower dose of niraparibExperimental Treatment2 Interventions
MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose.
Group II: Dose expansion_sub-population 2_higher dose of niraparibExperimental Treatment2 Interventions
MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.
Group III: Dose expansion_sub-population 1_lower dose of niraparibExperimental Treatment2 Interventions
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.
Group IV: Dose expansion_sub-population 1_higher dose of niraparibExperimental Treatment2 Interventions
MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.
Group V: Dose escalation of elimusertib_Part A.2Experimental Treatment2 Interventions
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.
Group VI: Dose escalation of elimusertib_Part A.1Experimental Treatment2 Interventions
Dose escalation will initiate with Part A.1 in which niraparib is used at a lower fixed dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elimusertib (BAY1895344)
2019
Completed Phase 1
~290
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,251 Previous Clinical Trials
25,336,902 Total Patients Enrolled
8 Trials studying Ovarian Cancer
382 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,772 Previous Clinical Trials
8,106,889 Total Patients Enrolled
24 Trials studying Ovarian Cancer
16,506 Patients Enrolled for Ovarian Cancer
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,865 Total Patients Enrolled
1 Trials studying Ovarian Cancer
150 Patients Enrolled for Ovarian Cancer

Media Library

Ovarian Cancer Research Study Groups: Dose escalation of elimusertib_Part A.1, Dose escalation of elimusertib_Part A.2, Dose expansion_sub-population 1_lower dose of niraparib, Dose expansion_sub-population 2_lower dose of niraparib, Dose expansion_sub-population 1_higher dose of niraparib, Dose expansion_sub-population 2_higher dose of niraparib
Ovarian Cancer Clinical Trial 2023: Elimusertib (BAY1895344) Highlights & Side Effects. Trial Name: NCT04267939 — Phase 1
~3 spots leftby Jul 2025
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