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ATR Inhibitor

Elimusertib + Chemotherapy for Pancreatic and Ovarian Cancer

Phase 1
Waitlist Available
Led By James M Cleary
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 histologically confirmed solid tumor malignancy that is not curable with standard approaches. Gemcitabine must be considered a standard therapy for the participant's malignancy
Participants must have a histologically confirmed advanced pancreatic adenocarcinoma or ovarian cancer (high grade serous ovarian, primary peritoneal or fallopian tube cancer) that is not curable with standard approaches. Patients with both metastatic pancreatic cancer and unresectable pancreatic cancer are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Who is the study for?
Adults with advanced pancreatic, ovarian, or other solid tumors that have spread and are not curable by standard treatments. Participants must have measurable disease, may have had prior gemcitabine treatment, and should not exceed two lines of cytotoxic chemotherapy. HIV-positive patients on effective therapy can join. Women of childbearing potential and men must use contraception during the trial.Check my eligibility
What is being tested?
The trial is testing a combination of gemcitabine (a chemotherapy drug) with elimusertib (an ATR inhibitor) to see if it's safe, find the best dose, and observe its effectiveness against advanced cancers like pancreatic and ovarian cancer. The goal is to determine whether this combo can shrink or stabilize tumors.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk; plus any unknown risks from elimusertib which could involve effects on DNA repair in cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is not curable with usual treatments and Gemcitabine is a standard option for me.
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I have advanced pancreatic or high-grade serous ovarian cancer that cannot be cured with standard treatments.
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My chemotherapy within 6 months of cancer recurrence counts as one treatment line.
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My ovarian cancer worsened within 6 months after my last platinum-based treatment.
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I have pancreatic cancer and received only one chemotherapy treatment for it when it spread.
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My brain cancer has not worsened 4 weeks after treatment, and I haven't taken steroids for 4 weeks.
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I have had one treatment for my incurable cancer or have a rare cancer with no standard treatment.
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My white blood cell count is healthy and I haven't taken specific blood cell boosters in the last 3 weeks.
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My kidney function, measured by creatinine clearance or GFR, is within the normal range.
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My hemoglobin level is at least 10 g/dL and I haven't had a blood transfusion in the last 3 weeks.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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I agree to use birth control during and 6 months after the study.
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I have had multiple prior treatments with targeted therapies or immunotherapy.
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I have previously been treated with gemcitabine.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer returned more than 6 months after my last chemotherapy.
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I stopped taking PARP inhibitors due to worsening condition or severe side effects.
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I have ovarian cancer and have had only one or no treatments after becoming resistant to platinum-based therapy.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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My hepatitis B virus load is undetectable with treatment.
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I have had no more than two rounds of chemotherapy.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I have a tumor that can be biopsied and another tumor that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of response (expansion cohort)
Incidence of adverse events
Maximum tolerated dose (MTD)
+3 more
Secondary outcome measures
Conversion of cancer with stable replication forks to one with unstable replication forks
Gemcitabine pharmacokinetics
Increase in deoxyribonucleic acid (DNA) damage level (expansion cohort)
+4 more
Other outcome measures
Pharmacodynamic (biological endpoints, toxicity and efficacy) parameters

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine, elimusertib)Experimental Treatment5 Interventions
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and elimusertib PO QD or BID on days 2-3 and 9-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial and collection of blood samples during screening and on days 1, 2, and 9-10 of cycle 1. Patients in the dose-expansion portion of the trial also undergo biopsies during screening and on day 9 of cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,582 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,708 Patients Enrolled for Ovarian Cancer
James M ClearyPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

BAY 1895344 (ATR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04616534 — Phase 1
Ovarian Cancer Research Study Groups: Treatment (gemcitabine, elimusertib)
Ovarian Cancer Clinical Trial 2023: BAY 1895344 Highlights & Side Effects. Trial Name: NCT04616534 — Phase 1
BAY 1895344 (ATR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04616534 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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,"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~5 spots leftby Jul 2024