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NCT04535401 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines
A Phase 1 study of Metastatic Colorectal Carcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 10
- Study locations
NCT04535401: Active Phase 1 study of Metastatic Colorectal Carcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04535401 is a Phase 1 study of Metastatic Colorectal Carcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 88-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (89% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04535401, a Phase 1 study of Metastatic Colorectal Carcinoma and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan, fluorouracil, and leucovorin, (called FOLFIRI in short) 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. Giving BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach and/or intestinal cancer.
Primary Outcome
A BOIN - Bayesian Optimal intervals trial design will be used to determine the MTD.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- DRUG Fluorouracil
- PROCEDURE Diagnostic Imaging
- DRUG Elimusertib
Study Locations (10)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
Maryland
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
- National Institutes of Health Clinical Center - Bethesda
California
- City of Hope Comprehensive Cancer Center - Duarte
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2025-04-29 |
| Phase | Phase 1 |
What the registry record for NCT04535401 still lists
NCT04535401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 88-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (89% lower).
The record links to 10 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04535401 lists 10 locations in 5 states (Missouri, Maryland, California).
Frequently Asked Questions
What is clinical trial NCT04535401 about?
NCT04535401 is a clinical study titled "Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines". This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that 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 NCT04535401?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-08-13. Estimated completion is 2025-04-29.
What conditions does trial NCT04535401 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8.
What interventions are being tested in trial NCT04535401?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Fluorouracil (DRUG), Diagnostic Imaging (PROCEDURE), Elimusertib (DRUG).
Who is sponsoring clinical trial NCT04535401?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04535401 being conducted?
This trial has 10 study locations across California, Maryland, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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