Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04514497 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 20
- Study locations
NCT04514497 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Lung Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT04514497, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IV Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Irinotecan Hydrochloride
- DRUG Elimusertib
Study Locations (20)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital - North Kansas City
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Connecticut
- Yale University - New Haven
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2026-03-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04514497
The ClinicalTrials.gov registry entry for NCT04514497 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (86% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04514497 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Missouri, Kansas, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04514497 about?
NCT04514497 is a clinical study titled "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". 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 (ad...
What is the current status of trial NCT04514497?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-10-20. Estimated completion is 2026-03-04.
What conditions does trial NCT04514497 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT04514497?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Irinotecan Hydrochloride (DRUG), Elimusertib (DRUG).
Who is sponsoring clinical trial NCT04514497?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04514497 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
RECRUITING · Phase 1
-
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
RECRUITING · Phase 1
-
Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes
RECRUITING · Phase 1
-
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
RECRUITING · Phase 1
-
Studying TAK-243 in Patients With Advanced Cancer
RECRUITING · Phase 1
Explore more on PlainTrial
Metastatic Malignant Solid Neoplasm
All registered trials for this condition
Stage IV Lung Cancer AJCC v8
All registered trials for this condition
Arizona
All trials with a study site in Arizona
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.