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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

Study 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 weeks3 visits

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.

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%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Dyspnea

22%

Abdominal pain

22%

Dizziness

22%

Insomnia

17%

Headache

17%

Platelet count decreased

17%

Mucositis oral

17%

Creatinine increased

13%

Sinus tachycardia

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

Anxiety

Alanine aminotransferase increased

Dehydration

Blood bilirubin increased

Urinary tract infection

Dry mouth

Back pain

Cough

Hypertension

Non-cardiac chest pain

Esophageal ulcer

Skin tear

Diarrhea

Edema limbs

Leukocytosis

Syncope

Head injury

Oral petechia

Sinus pain

Unknown infection

Ascites

Bruising

Itchy eyes

Flu like symptoms

Hoarseness

Peripheral sensory neuropathy

Sore throat

Upper respiratory infection

Neutrophil count decreased

Lung infection

White blood cell decreased

Hypotension

Hyponatremia

Hypokalemia

Depression

Postnasal drip

Hyperkalemia

Bloating

Hot flashes

Hyperglycemia

Hematuria

Tremor

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,964 Total Patients Enrolled

8 Trials studying Ovarian Cancer

382 Patients Enrolled for Ovarian Cancer

GlaxoSmithKlineIndustry Sponsor

4,751 Previous Clinical Trials

8,067,458 Total Patients Enrolled

23 Trials studying Ovarian Cancer

16,436 Patients Enrolled for Ovarian Cancer

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,261,925 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for enrolment in this experimental research?

"Per the clinicaltrials.gov website, this medical trial is still seeking participants as of November 22nd 2022, having first been posted on February 26th 2020."

Answered by AI

Are there any extant experiments involving Niraparib?

"Currently, 99 Niraparib trials are underway globally; 13 of these being in the penultimate phase. While Washington D.C, is currently hosting the majority of studies involving this medication, there exists a total 2817 trial locations worldwide."

Answered by AI

How many participants are engaging in this research project?

"Affirmative. According to clinicaltrials.gov, the research trial is recruiting participants at present time. It was initially published on February 26th 2020 and its details were last modified on November 22nd 2022. The study requires 89 individuals from 4 sites in order to be completed successfully."

Answered by AI

Is this trial unprecedented in its methodology?

"At present, Myriad Genetics have conducted 99 separate clinical trials testing Niraparib in 485 cities across 49 countries. The original trial that concluded its Phase 3 drug approval stage began in 2016 and included 733 patients; since then an additional 17 studies have been undertaken."

Answered by AI

Has Niraparib received authorization from the US Food and Drug Administration?

"Niraparib's safety rating is 1, as the trial has only reached Phase 1. This means that while there have been some studies conducted on efficacy and safety, more research needs to be done before it can reach a higher score."

Answered by AI

How many venues are currently hosting this experiment?

"Patients can be enrolled in this study at Cleveland Clinic (Cleveland, Ohio), University of Texas MD Anderson Cancer Center (Houston, Texas), Dana-Farber Cancer Institute (Boston Massachusetts) and an additional 4 sites."

Answered by AI

Recent research and studies

The Cancer JournalJournal

DNA Damage Repair Inhibitors—combination Therapies

Smith, Gabriella, Zachary Alholm, Robert L. Coleman, and Bradley J. Monk. 2021. “DNA Damage Repair Inhibitors—combination Therapies”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000561.

The Cancer JournalJournal

DNA Damage Repair Inhibitors—combination Therapies

clinicaltrials.govStudy

ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

2020. "ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04267939.