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Topoisomerase I inhibitor

BAY 1895344 + Chemotherapy for Lung Cancer

Phase 1

Waitlist Available

Led By Thatcher Heumann

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a solid tumor for which irinotecan or topotecan is considered standard of care

Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-treatment

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of BAY 1895344 when given with usual chemotherapy drugs to treat patients with advanced solid tumors, with a focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer.

Who is the study for?

Adults with advanced solid tumors, specifically small cell lung cancer, neuroendocrine carcinoma, or pancreatic cancer that have worsened after standard treatment. Must be able to swallow pills and not have severe heart disease. Eligible even if HIV-positive or with treated hepatitis B/C as long as it's under control. Cannot join if pregnant/breastfeeding or on certain drugs affecting liver enzymes.Check my eligibility

What is being tested?

The trial is testing the effectiveness of adding a new anti-cancer drug called BAY 1895344 to usual chemotherapy (irinotecan or topotecan). The goal is to see if this combination can better halt tumor growth compared to standard chemotherapy alone in patients with specific advanced cancers.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system, fatigue, digestive issues like nausea and diarrhea from chemotherapy, potential liver enzyme changes due to BAY 1895344, and other common chemo-related symptoms such as hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer treatment includes irinotecan or topotecan.

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My kidney function, measured by GFR, is normal or above 60.

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My cancer has spread, can't be surgically removed, and has worsened after treatment.

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I have at least one tumor that can be measured, not including the one to be biopsied.

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I am 18 years old or older.

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My hepatitis B virus load is undetectable with treatment.

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My brain scans show no worsening after treatment for brain metastases and I have no symptoms.

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I have advanced lung, neuroendocrine, or pancreatic cancer that has worsened after treatment.

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I had hepatitis C but have been treated and cured.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) (Dose Escalation Phase)

Occurrence of grade 4 hematologic AEs (Dose Expansion Phase)

Secondary outcome measures

Area under the concentration-time curve (AUC)

Changes in tumor expression patterns of gamma-H2AX

Changes in tumor expression patterns of pS343-NBS1

+5 more

Other outcome measures

Tumor ATM expression loss

Tumor deoxyribonucleic acid damage response (DDR) gene mutations present

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort III (elimusertib, topotecan)Experimental Treatment6 Interventions

Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

Group II: Cohort II (elimusertib, irinotecan)Experimental Treatment6 Interventions

Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

Group III: Cohort I (elimusertib, irinotecan)Experimental Treatment6 Interventions

Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~850

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Topotecan Hydrochloride

2013

Completed Phase 3

~6120

Biospecimen Collection

2004

Completed Phase 2

~1730

Irinotecan Hydrochloride

2010

Completed Phase 3

~1940

Computed Tomography

2017

Completed Phase 2

~2720

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,057 Total Patients Enrolled

Thatcher HeumannPrincipal InvestigatorYale University Cancer Center LAO

Satya DasPrincipal InvestigatorYale University Cancer Center LAO

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Irinotecan Hydrochloride (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04514497 — Phase 1

Lung Cancer Research Study Groups: Cohort I (elimusertib, irinotecan), Cohort II (elimusertib, irinotecan), Cohort III (elimusertib, topotecan)

Lung Cancer Clinical Trial 2023: Irinotecan Hydrochloride Highlights & Side Effects. Trial Name: NCT04514497 — Phase 1

Irinotecan Hydrochloride (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04514497 — Phase 1

Frequently Asked Questions

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

Has Elimusertib received regulatory clearance from the Food and Drug Administration?

"The safety of Elimusertib is evaluated as a 1 on the scale from 1 to 3, given that this is a Phase 1 trial with limited data regarding efficacy and precautionary measures."

Answered by AI

What conditions is Elimusertib typically employed to manage?

"The drug elimusertib has demonstrated efficacy in the treatment of acute myelocytic leukemia, colorectal carcinoma and ovarian cancer."

Answered by AI

What is the sample size of participants in this experiment?

"Affirmative. As per the information on clinicaltrials.gov, this medical trial is recruiting presently and was originally posted on February 11th 2021. In total, 96 patients are required to be recruited from 13 different sites."

Answered by AI

What other investigations have included the use of Elimusertib?

"At the moment, 314 clinical trials are ongoing in regards to Elimusertib. 67 of these are Phase 3 studies and they can be found at 11052 sites across Woolloongabba in Queensland."

Answered by AI

Is this experiment actively enlisting participants?

"Affirmative, according to clinicaltrials.gov the recruitment for this experiment has been ongoing since February 11th 2021 and was recently updated on November 25th 2022. A total of 96 participants are needed from 13 sites around the country."

Answered by AI

What are the anticipated outcomes of this experiment?

"This medical trial has one main objective that will be measured up to 6 months post-treatment: determining the Maximum Tolerated Dose. The secondary objectives are assessing Overall Survival, Objective Response Rate and Maximum Concentration of the drug being tested, all of which will be determined using Kaplan-Meier Methodology, RECIST 1.1 criteria on 12 week CT scans and plasma collection from Cycle 1 respectively."

Answered by AI

Are there a plethora of research centers executing this clinical experiment within the city limits?

"The current trial is operating at a total of 13 different medical sites, including Nashville, Saint Louis and Saint Peters. To reduce the burden of travel related to participation in this study, we recommend selecting the clinic closest to you if you decide to join."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer

2021. "Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04514497.

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