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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

Must not have

Subjects with a gastrointestinal disorder or malabsorption that could potentially affect the absorption of the study drug are excluded

Participants with known untreated brain metastases are excluded from this clinical trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 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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My kidney function, measured by creatinine clearance or GFR, is within the normal range.

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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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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any stomach or intestine problems that affect how I absorb medication.

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I do not have untreated brain metastases.

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I am not pregnant or breastfeeding.

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I can safely undergo tumor biopsies.

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I have never been treated with an ATR inhibitor.

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I am allergic to medications similar to elimusertib or gemcitabine.

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I have not had radiation on more than 25% of my bone marrow.

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I cannot swallow pills.

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I do not have any severe illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD)

Overall response rate (ORR) (expansion cohort)

Secondary study objectives

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 study objectives

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 QD or PO 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

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030