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BAY 1895344 + Chemotherapy for Bladder Cancer
Study Summary
This trial is testing a new drug, BAY 1895344, to see if it's effective and has minimal side effects when combined with chemotherapy to treat patients with advanced solid tumors or urothelial cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Trial Design
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Who is running the clinical trial?
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- I am not on any strong medication that affects liver enzymes or can't switch to another.I can take care of myself but might not be able to do heavy physical work.Your hemoglobin level is at least 9 grams per deciliter.I have previously received immune checkpoint inhibitor therapy.I have a preserved tissue sample available.I haven't had chemotherapy, radiotherapy, or targeted therapies like PARP inhibitors in the specified time before joining the study.I am 18 years old or older.I have been treated with PARP inhibitors before.My hepatitis B is under control with treatment.The doctor thinks you have less than 6 weeks to live.You have a low level of white blood cells.Your neutrophil count is at least 1,500 cells per microliter.I have not been treated with ATR inhibitors or any experimental drugs.Your total bilirubin level should be less than or equal to 2 mg/dL.My brain scans show no worsening after treatment for brain metastases.My brain metastases are stable, not requiring immediate treatment.I have no active cancer needing treatment, except for certain skin cancers or prostate cancer treated with hormone therapy.I have moderate to severe hearing loss.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.You have had allergic reactions to drugs similar to BAY 1895344 or other drugs used in the study.My bladder cancer cannot be removed by surgery.I do not have severe nerve damage.I am not breastfeeding, or I will stop if I start the treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.Your platelet count is at least 100,000 per microliter.My advanced cancer is measurable and may be treated with cisplatin.Your AST and ALT blood levels must be within a certain range.I have received less than 300 mg/m^2 of cisplatin.I had hepatitis C but have been treated and cured.My kidney function is within the safe range for the trial.
- 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.
- Group 1: Arm II (cisplatin, gemcitabine, elimusertib)
- Group 2: Arm I (cisplatin, elimusertib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
To what extent are individuals put at risk by Cisplatin treatments?
"Since there is limited clinical data on Cisplatin's safety and efficacy, this medication has been assigned a score of 1."
What is the aggregate amount of individuals involved in this clinical experiment?
"The current study necessitates the inclusion of 74 individuals who meet its predetermined eligibility requirements. These patients can take part in this trial at various sites, including the National Cancer Institute Developmental Therapeutics Clinic in Bethesda, Maryland and NIH Clinical Center in Pittsburgh, Pennsylvania."
Is this research initiative currently accepting participants?
"As indicated on clinicaltrials.gov, this investigation is actively searching for participants. The trial was originally posted in the beginning of 2021 and it has been revised up until September 23rd 2022."
Are there any other trials that have studied the efficacy of Cisplatin?
"At present, 1027 active clinical trials are being conducted on Cisplatin with 350 studies in Phase 3. The bulk of the investigations into this drug are occurring within Shanghai; however, there is an extensive network of 53543 medical sites researching it too."
What are the typical applications of Cisplatin?
"Cisplatin has proven useful in the treatment of neoplasm metastasis and is also used to treat various forms of cancer, including those affecting the urinary bladder, advanced testicular tumors, and small cell lung carcinomas."
Are there multiple venues providing access to this experiment?
"Patients are being recruited to take part in this trial at the National Cancer Institute Developmental Therapeutics Clinic located in Bethesda, Maryland, along with 8 other sites such as the NIH Clinical Center and University of Pittsburgh Cancer Institute (UPCI) in Sacramento."
What objectives are being sought through this clinical experiment?
"This experiment, which is to be conducted over a period of 21 days in total, has two primary goals. The first being the assessment of adverse effects and the second involves gauging ATM expression using immunohistochemistry (IHC). Secondary objectives include analyzing pharmacokinetic parameters such as AUC and Cmax, with comparisons made against historical data on gemcitabine. Furthermore, researchers will also consider any changes to BAY 1895344 exposure that can be attributed to cisplatin administration."
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