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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
No Placebo-Only Group
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
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 5 and cycle 1 day 21, each cycle is 28 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 5 and cycle 1 day 21, each cycle is 28 days.
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 • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
22%
Dyspnea
17%
Platelet count decreased
17%
Headache
17%
Mucositis oral
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Cough
9%
Dehydration
9%
Urinary tract infection
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Upper respiratory infection
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Bruising
4%
Esophageal ulcer
4%
Hyperkalemia
4%
Peripheral sensory neuropathy
4%
Leukocytosis
4%
White blood cell decreased
4%
Postnasal drip
4%
Skin tear
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,275 Previous Clinical Trials
25,539,385 Total Patients Enrolled
8 Trials studying Ovarian Cancer
382 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,812 Previous Clinical Trials
8,382,234 Total Patients Enrolled
24 Trials studying Ovarian Cancer
16,468 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
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation of elimusertib_Part A.1
- Group 2: Dose escalation of elimusertib_Part A.2
- Group 3: Dose expansion_sub-population 1_lower dose of niraparib
- Group 4: Dose expansion_sub-population 2_lower dose of niraparib
- Group 5: Dose expansion_sub-population 1_higher dose of niraparib
- Group 6: Dose expansion_sub-population 2_higher dose of niraparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.