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ATR Inhibitor
BAY 1895344 + FOLFIRI for Stomach and Intestinal Cancer
Phase 1
Waitlist Available
Led By Anuradha Krishnamurthy
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
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
International normalization ratio (INR) =< 1.5 × ULN unless participant is receiving anticoagulant therapy, in which case prothrombin time (PT) or activated partial thromboplastin time (aPTT) should be within expected therapeutic range of anticoagulants. If patient has a new diagnosis of venous thromboembolism (VTE), then patient should be appropriately anticoagulated with low molecular weight heparin (LMWH) or direct acting oral anticoagulants (DOACs) and be clinically stable for at least 1 week post treatment onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post treatment
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat stomach or intestinal cancer. The first drug, BAY 1895344, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The second drug, a chemotherapy drug called FOLFIRI, works in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial is testing to see if the combination of these two drugs may help shrink advanced or metastatic stomach and/or intestinal cancer.
Who is the study for?
Adults with advanced or metastatic stomach/intestinal cancer who've progressed after first-line therapy can join. They must have adequate organ function, no severe reactions to similar drugs, and agree to use contraception. Those with certain viral infections must be stable on treatment without interactions.Check my eligibility
What is being tested?
The trial is testing BAY 1895344 combined with FOLFIRI chemotherapy against cancers of the stomach and intestines. It aims to find the best dose and assess benefits/side effects by seeing if this combination can shrink tumors more effectively than standard treatments.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues like fatigue, digestive problems, blood cell count changes, as well as potential drug-specific effects such as allergic reactions or enzyme inhibition that could affect cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My blood clotting levels are normal or managed if I'm on blood thinners.
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I am willing to have biopsies taken from my tumor for research.
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My kidney function, measured by GFR, is normal or near normal.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
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) of elimusertib (BAY 1895344) in combination with irinotecan, fluorouracil, and leucovorin (FOLFIRI)
Secondary outcome measures
ATM status
AUC and Cmax of BAY 1895344
Area under curve (AUC) and concentration maximum (Cmax) of irinotecan and 5-FU
+5 moreOther outcome measures
Incidence of adverse events
Status of deoxyribonucleic acid damage repair (DDR) genes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (elimusertib, FOLFIRI)Experimental Treatment7 Interventions
Patients receive elimusertib PO QD on days 2, 3, 16, and 17 and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Leucovorin Calcium
2011
Completed Phase 3
~12290
Biopsy
2014
Completed Phase 4
~1090
Fluorouracil
2014
Completed Phase 3
~11540
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,659 Previous Clinical Trials
40,924,599 Total Patients Enrolled
Anuradha KrishnamurthyPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it won't interfere with this study.I have a stomach or intestine condition that affects how I absorb pills.I do not have any unmanaged ongoing illnesses.I am fully active or can carry out light work.You have either colorectal cancer that has not responded to irinotecan treatment or gastroesophageal cancer that has not responded to first-line therapy. If you have a specific genetic issue called mismatch repair deficiency, you should also have not responded to immunotherapy.I have GI cancer that has worsened after treatment and can be measured. FOLFIRI is a treatment option for me.I am not on any strong medication that affects my liver enzyme levels, or I can switch them.I agree to use effective birth control during and for 6 months after the study.I am not pregnant or breastfeeding.I have had allergic reactions to specific cancer drugs or similar compounds.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.My blood clotting levels are normal or managed if I'm on blood thinners.I have GI cancer that has worsened after treatment, and FOLFIRI is a suitable next step for me.I have another cancer type, but it won't affect this trial's treatment.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am willing to have biopsies taken from my tumor for research.I have tolerated irinotecan treatment in the past.My kidney function, measured by GFR, is normal or near normal.My hepatitis B is under control with treatment that won't affect the study therapy.My brain cancer has not worsened after treatment.I have recovered from side effects of previous cancer treatments, except for hair loss.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I am 18 years old or older.My cancer has worsened despite treatment.I have been treated with an ATR inhibitor before.I am HIV positive, on effective treatment, and my viral load is undetectable.I had hepatitis C but am cured, or I'm being treated with undetectable viral load without affecting the study therapy.I am willing to have biopsies taken from my tumor for research.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (elimusertib, FOLFIRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many health care institutions are presently conducting this research in the region?
"The team is currently enrolling patients at 9 medical centres, located in Saint Louis, New york and Saint Peters along with other cities. To reduce travel burdens for participants, it's advised to select the clinic nearest you."
Answered by AI
Is it still possible for participants to join this clinical investigation?
"Affirmative, the details on clinicaltrials.gov indicate that this trial is currently enrolling participants. The study was initially posted on March 15th 2021 and last edited on September 16th 2022; it requires 90 patients to be enrolled across 9 locations."
Answered by AI
What medical ailments has Elimusertib been approved to address?
"Elimusertib is employed to treat actinic keratosis and other medical conditions such as macrocytic anemia, mineral supplementation therapy, and malignant neoplasms."
Answered by AI
Are there potential risks associated with Elimusertib treatment?
"With limited data indicating efficacy and safety, Elimusertib was cautiously assigned a score of 1."
Answered by AI
Are there records of prior experiments with Elimusertib?
"Elimusertib is currently a part of 522 active clinical trials, with 147 in Phase 3. There are multiple centres operating studies for this medication located across the globe; Shanghai alone hosts 24 464 such sites."
Answered by AI
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