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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
Dose escalation (Part A): recurrent advanced solid tumors, excluding prostate cancer, who experienced disease progression after treatment with standard of care therapy for metastatic disease.
Dose expansion (Part B): recurrent EOC, fallopian tube or primary peritoneal cancer
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Participants have advanced solid tumors (except prostate cancer) that have come back after standard treatments.
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Participants with recurrent ovarian, fallopian tube, or primary peritoneal cancer can take part in the dose expansion phase.
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You have not used a certain type of medication before and your cancer did not respond well to platinum-based treatment. You have not tried more than 3 different treatments since your cancer stopped responding to platinum-based treatment.
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You have a performance status score of 0 or 1 according to the ECOG scale.
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You are expected to live for at least 12 more weeks.
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You need to have normal blood clotting.
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You have experienced disease progression while taking a specific type of medication called PARPi, and you have not started a new treatment after that.
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In one part of the study, participants need to have a specific genetic issue in their tumor. In another part of the study, the presence or absence of a specific biomarker does not affect enrollment.
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You must have signs of your disease getting worse and have measurable disease according to specific guidelines.
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The sample of your tumor tissue must be from the past year, or you will need to get a new biopsy.

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%
Creatinine increased
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Back pain
9%
Dehydration
9%
Urinary tract infection
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Skin tear
4%
Oral petechia
4%
Sinus pain
4%
Depression
4%
Head injury
4%
Esophageal ulcer
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypokalemia
4%
Sore throat
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Peripheral sensory neuropathy
4%
Syncope
4%
Itchy eyes
4%
Leukocytosis
4%
Hyponatremia
4%
Flu like symptoms
4%
Edema limbs
4%
Postnasal drip
4%
Hypotension
4%
Hyperkalemia
4%
Hoarseness
4%
Bloating
4%
Diarrhea
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
4%
Tremor
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
2,233 Previous Clinical Trials
25,326,303 Total Patients Enrolled
8 Trials studying Ovarian Cancer
382 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,748 Previous Clinical Trials
8,067,353 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
~3 spots leftby Apr 2025