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Elimusertib + Chemotherapy for Pancreatic and Ovarian Cancer
Study Summary
This trial is testing a new combination cancer treatment to see what dose is best, what benefits it has, and what side effects it causes.
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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- Your AST and ALT levels in your blood should not be more than 3 times the normal range set by the hospital.I do not have any stomach or intestine problems that affect how I absorb medication.I do not have untreated brain metastases.I have advanced pancreatic or high-grade serous ovarian cancer that cannot be cured with standard treatments.My chemotherapy within 6 months of cancer recurrence counts as one treatment line.I have pancreatic cancer and received only one chemotherapy treatment for it when it spread.My ovarian cancer worsened within 6 months after my last platinum-based treatment.My brain cancer has not worsened 4 weeks after treatment, and I haven't taken steroids for 4 weeks.I have had one treatment for my incurable cancer or have a rare cancer with no standard treatment.My white blood cell count is healthy and I haven't taken specific blood cell boosters in the last 3 weeks.I am not pregnant or breastfeeding.I haven't had chemotherapy, targeted therapy, or immunotherapy in the last 3 weeks.I can safely undergo tumor biopsies.My kidney function, measured by creatinine clearance or GFR, is within the normal range.I had another type of cancer but have been cancer-free for over 3 years.My hemoglobin level is at least 10 g/dL and I haven't had a blood transfusion in the last 3 weeks.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I am not on any strong medication that affects liver enzymes or can't switch to another.I have had multiple prior treatments with targeted therapies or immunotherapy.My cancer is not curable with usual treatments and Gemcitabine is a standard option for me.I agree to use birth control during and 6 months after the study.You have had another type of cancer, but it won't affect the study's ability to see if the new treatment works.I have previously been treated with gemcitabine.I have recovered from any major surgery I had within the last 4 weeks.I am 18 years old or older.I have never been treated with an ATR inhibitor.You need to have at least 3,000 white blood cells per microliter of blood.I can take care of myself but might not be able to do heavy physical work.Patients must have a specific amount of disease that can be measured by the doctor using certain guidelines.I am allergic to medications similar to elimusertib or gemcitabine.I have not had radiation on more than 25% of my bone marrow.I haven't had a significant cancer other than skin cancer or completely treated in-situ cancer in the last 2 years.I have not had radiotherapy in the last 4 weeks.My cancer returned more than 6 months after my last chemotherapy.I stopped taking PARP inhibitors due to worsening condition or severe side effects.I have recovered from side effects of previous cancer treatments, except for hair loss or low lymphocyte count.I have ovarian cancer and have had only one or no treatments after becoming resistant to platinum-based therapy.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I cannot swallow pills.Your platelet count is at least 100,000 per microliter.My hepatitis B virus load is undetectable with treatment.Your albumin level in the blood is at least 2.8 mg/dL.Your total bilirubin level should not be higher than 1.5 times the normal limit at the study site.I have had no more than two rounds of chemotherapy.I do not have any severe illnesses that would stop me from following the study's requirements.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have a tumor that can be biopsied and another tumor that can be measured.
- Group 1: Treatment (gemcitabine, elimusertib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
To what extent has Gemcitabine been proven to be a secure and beneficial treatment?
"Our experts at Power rated Gemcitabine's safety as 1, which is indicative of this Phase 1 trial and limited data supporting its efficacy."
What goals is this trial attempting to achieve?
"The primary endpoint of this clinical trial, which will be monitored for up to one year, is the Maximum Tolerated Dose (MTD). Secondary objectives include a Gemcitabine pharmacokinetic analysis that examines CDA phenotypes relative to gemcitabine half-life and AUC as well as a dFdU/gemcitabine metabolic ratio. Additionally, replication stress will be evaluated through gene expression profiling and protein level investigations into phosphorylated KAP1, RPA32, cyclin E, and MYC in correlation with objective response rate (ORR) and progression free survival time. Lastly,"
Could you detail the other investigations conducted involving Gemcitabine?
"Currently, 446 trials involving Gemcitabine are ongoing; of these experiments 134 have moved to Phase 3. Although the vast majority of studies utilizing this drug are located in Adelaide, South Australia, there are 24567 centers across the world performing research with it."
Is there any opportunity to join this research effort at the present time?
"Affirmative. According to clinicaltrials.gov, this research is actively accepting participants after being published on the 12th of February 2021 and last edited 10th August 2022. A total of 36 patients need to be recruited from 3 distinct medical locations."
How many individuals are participating in this medical experiment?
"Affirmative. Clinicaltrials.gov confirms that this research investigation, which was first published on February 12th 2021, is still actively recruiting participants. 36 people are required from 3 distinct clinical settings."
In what circumstances is Gemcitabine routinely prescribed?
"Gemcitabine is the preferred treatment for small cell lung cancer (SCLC), but it can also provide relief to those suffering from head and neck carcinoma, pancreatic adenocarcinoma locally advanced, as well as cervical cancers."
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