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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
Solid Tumors

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.

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%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Hyperkalemia

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

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