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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 cycle 1 day 5 and cycle 1 day 21, each cycle is 28 days.
Awards & highlights

Summary

This trial is testing a combination of two drugs, elimusertib and niraparib, to treat patients with advanced solid tumors and ovarian cancer. Elimusertib stops tumor cells from growing, and niraparib helps kill tumor cells or makes them more sensitive to treatment. The study aims to find the best dose and understand how the body handles these drugs.

Eligible Conditions
  • Ovarian Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 5 and cycle 1 day 21, each cycle is 28 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 5 and cycle 1 day 21, each cycle is 28 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
AUC(0-8)md of elimusertib after multiple dose administration

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dizziness
22%
Dyspnea
22%
Insomnia
22%
Abdominal pain
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Hypertension
9%
Dry mouth
9%
Cough
9%
Dehydration
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
White blood cell decreased
4%
Head injury
4%
Hyperglycemia
4%
Hypokalemia
4%
Hyponatremia
4%
Depression
4%
Esophageal ulcer
4%
Flu like symptoms
4%
Bruising
4%
Leukocytosis
4%
Skin tear
4%
Oral petechia
4%
Hypotension
4%
Tremor
4%
Diarrhea
4%
Itchy eyes
4%
Postnasal drip
4%
Edema limbs
4%
Upper respiratory infection
4%
Hoarseness
4%
Hot flashes
4%
Hyperkalemia
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
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
~2400

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,260 Previous Clinical Trials
25,309,431 Total Patients Enrolled
8 Trials studying Ovarian Cancer
382 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,793 Total Patients Enrolled
24 Trials studying Ovarian Cancer
16,506 Patients Enrolled for Ovarian Cancer
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,852 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 Sep 2025
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