Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04514497
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Lung Small Cell Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Neuroendocrine Carcinoma
  • Metastatic Pancreatic Adenocarcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Unresectable Lung Small Cell Carcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Neuroendocrine Carcinoma
  • Unresectable Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Elimusertib — DRUG
    Given PO
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Topotecan Hydrochloride — DRUG
    Given IV

Study Details

This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.

Key Dates

Start date
Oct 20, 2021
Status verified
Mar 2026
Primary completion
Feb 15, 2025
Completion
Mar 4, 2027

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (elimusertib, irinotecan)
    Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
  • Experimental: Cohort II (elimusertib, irinotecan)
    Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
  • Experimental: Cohort III (elimusertib, topotecan)
    Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib [ Time Frame: Up to 21 days (first treatment cycle) ]

Locations (23)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Yale UniversityNew HavenConnecticut06520-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
University of Kansas Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
Mayo Clinic in RochesterRochesterMinnesota55905-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

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By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAYale University· New Haven, CTSmilow Cancer Hospital Care Center-Trumbull· Trumbull, CTMayo Clinic in Florida· Jacksonville, FLUniversity of Kansas Clinical Research Center· Fairway, KS

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