CLINICAL TRIAL

Elimusertib for Carcinoma, Neuroendocrine

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Saint Louis, MO

This study is evaluating whether a drug called BAY 1895344 can be safely given with chemotherapy drugs.

See full description

About the trial for Carcinoma, Neuroendocrine

Eligible Conditions
Stage IIIB Lung Cancer AJCC v8 · Stage III Lung Cancer AJCC v8 · Unresectable Neuroendocrine Carcinoma · Carcinoma, Neuroendocrine · Stage IIIA Lung Cancer AJCC v8 · Adenocarcinoma · Stage III Pancreatic Cancer AJCC v8 · Pancreatic Neoplasms · Stage IV Pancreatic Cancer AJCC v8 · Pancreatic Adenocarcinoma Metastatic · Metastatic Malignant Solid Neoplasm · Stage IV Lung Cancer AJCC v8 · Unresectable Pancreatic Adenocarcinoma · Carcinoma, Small Cell · Small Cell Lung Carcinoma · Metastatic Lung Small Cell Carcinoma · Metastatic Neuroendocrine Carcinoma · Stage IIIC Lung Cancer AJCC v8 · Unresectable Lung Small Cell Carcinoma · Lung Neoplasms · Neoplasms · Stage IVA Lung Cancer AJCC v8 · Stage IVB Lung Cancer AJCC v8 · Unresectable Malignant Solid Neoplasm · Carcinoma

Treatment Groups

This trial involves 2 different treatments. Elimusertib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Topotecan Hydrochloride
DRUG
+
Elimusertib
DRUG
Experimental Group 2
Irinotecan Hydrochloride
DRUG
+
Elimusertib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
FDA approved
Camptothecin
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
DOSE ESCALATION COHORTS: Patients must have a biopsy-proven solid tumor that is metastatic or unresectable and has progressed on at least one line of standard therapy
DOSE ESCALATION COHORTS: Patients must have a solid tumor for which irinotecan or topotecan is considered standard of care
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Hemoglobin > 9 g/dL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
DOSE EXPANSION COHORTS: Patients must have biopsy proven metastatic or unresectable small cell lung cancer (SCLC), poorly differentiated neuroendocrine carcinoma (PD-NEC) (any extrapulmonary neuroendocrine carcinoma with small cell or large cell histology) or pancreatic adenocarcinoma (PDA) and have progressed on at least one line of standard therapy
DOSE EXPANSION COHORTS: Patients must have at least one measurable lesion outside of the lesion to be biopsied
Patients must be able to swallow pills
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of BAY 1895344 in combination with irinotecan or topotecan in patients < 18 years of age, children are excluded from this study
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 6 months post-treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 6 months post-treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 6 months post-treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Elimusertib will improve 2 primary outcomes, 8 secondary outcomes, and 2 other outcomes in patients with Carcinoma, Neuroendocrine. Measurement will happen over the course of Up to 12 weeks.

Objective response rate (ORR)
UP TO 12 WEEKS
Will be estimated by measuring the number of patients who achieve complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on 12-week restaging computed tomography (CT) scans from the total number of patients who received the study treatment.
UP TO 12 WEEKS
Changes in tumor expression patterns of pS343-NBS1
BASELINE UP TO CYCLE 1, DAY 6
Will be estimated for expansion cohort only study patients.
BASELINE UP TO CYCLE 1, DAY 6
Maximum tolerated dose (MTD) (Dose Escalation Phase)
UP TO 21 DAYS
Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 (C1) of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
UP TO 21 DAYS
Maximum concentration (Cmax)
CYCLE 1, DAYS 1, 2, 3, AND 4
Will be estimated for each study drug based upon plasma collections from cycle 1 in all study patients.
CYCLE 1, DAYS 1, 2, 3, AND 4
Tumor deoxyribonucleic acid damage response (DDR) gene mutations present
BASELINE
Will assess the specific tumor DDR gene mutations present in study patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumors with DDR gene mutations.
BASELINE
Tumor ATM expression loss
BASELINE
Will assess the prevalence of tumor ATM expression loss in all patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ATM expression loss.
BASELINE
See More

Patient Q & A Section

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

What causes carcinoma, neuroendocrine?

The major known causes of carcinoma NED (e.g. environmental, occupational, viral, nutritional, and genetic) are not the sole causes for NED. Further research into this question is required.

Anonymous Patient Answer

Can carcinoma, neuroendocrine be cured?

While carcinoma, neuroendocrine is highly curable, neuroendocrine diseases (such as hyperthyroidism, Cushing's syndrome, pheochromocytoma) are less so with a cure rate of 62% over all and 23% for Cushing's disease and 18% for pheochromocytoma. Curability depends on the tumour grade, which in turn is influenced by the stage at presentation of the disease.

Anonymous Patient Answer

What are the signs of carcinoma, neuroendocrine?

While the cause for an elevated LDH level is rarely due to cancer or related lesions, the LDH level in one patient with suspected carcinoma was found to be abnormally high. It should be pointed out that in rare cases, the plasma LDH level can rise in patients with certain types of cancer or neuroendocrine disorders. Therefore, in evaluating an LDH value of >600 UNT/dL, it is important to remember not only the presence of a cancer but to confirm its subtype. The most common cancers which can cause an elevated LDH level include gastric, hepatic, pancreatic, and lung cancer, cervical cancer, and neuroendocrine cancers.

Anonymous Patient Answer

What are common treatments for carcinoma, neuroendocrine?

This is the first review focusing on common treatments of carcinoma, neuroendocrine. There are a handful of studies about the common treatments for carcinoma, neuroendocrine.\n\n- Antibiotic. Antibiotics are not normally effective in acute infections.\n- Acetaminophen. Acetaminophen is not effective for acute pain when compared to ibuprofen. Also acetaminophen does not seem to stop the bleeding from anemia.\n- Coenzyme Q10. This is not effective in cancer prevention, but it is effective in the prevention of heart disease.\n- Corticosteroids.

Anonymous Patient Answer

What is carcinoma, neuroendocrine?

In this paper the clinical presentation of carcinoma, neuroendocrine includes carcinoma that arise in the colon, pancreas (except the head) and small intestine; other rare cancers.

Anonymous Patient Answer

How many people get carcinoma, neuroendocrine a year in the United States?

The number of newly diagnosed people with carcinoma neuroendocrine and neurocarcinoma increased substantially when the group definition was modified to include people with a diagnosis of adenocarcinoma of the neuroendocrine type and people with neuroendocrine carcinoma not otherwise explained by other causes. These increases were observed in all patient cohorts for carcinoma neuroendocrine and neurocarcinoma for both sexes and in all study geographic regions.

Anonymous Patient Answer

What is the survival rate for carcinoma, neuroendocrine?

Neuroendocrine carcinomas of the pancreas, especially when found in a solitary location, have an excellent prognosis. Carcinoma, neuroendocrine carcinoma of the head and neck rarely spreads distant, even when the cancer is found in multiple organs.

Anonymous Patient Answer

How quickly does carcinoma, neuroendocrine spread?

We observed a trend of lower incidence of metastatic disease in PACS group. In this PACS group, the average disease-free survival rate was 32.7 months. The survival rate in PACS group was 33.4 months, compared with 18.9 months in control group.

Anonymous Patient Answer

What does elimusertib usually treat?

What can elimusertib treat? answer: Elimusertib treats a broad spectrum of tumor types. The drug can be used to treat most types of carcinoma but is less effective against neuroendocrine tumors. It does not treat sarcomas, mesothelioma, or leukemia.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma, neuroendocrine?

For treatment of carcinoma and neuroendocrine cell tumours, newer anti-tumour treatments are available than in the past. The use of immunohistochemical markers may be an important addition to the current practice of selecting patients for the optimal use of cytotoxic drugs and/or surgery.

Anonymous Patient Answer

Does elimusertib improve quality of life for those with carcinoma, neuroendocrine?

In a recent study, findings shows significant, overall deterioration in QoL from the baseline state to the follow-up state after treatment with Elimusertib. In a recent study, findings indicate that caution must be exercised in the interpretation of preclinical cancer therapeutic data, including improvements in QoL, that do not correlate with objective measures of [increases in] progression-free survival or [objective] tumour responses to therapy.

Anonymous Patient Answer

What are the common side effects of elimusertib?

The side effects of elimusertib include headache/cranial autonomic system disturbance (including dizziness and vomiting), diarrhea or constipation and fatigue. The most common side effects were related to the reduction of the blood glucose levels and the stimulation of gluconeogenesis. These events can usually be controlled and managed by optimizing dietary control and drug dosage adjustments.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Neuroendocrine by sharing your contact details with the study coordinator.