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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

NCT04535401 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-10

No results posted yet for this 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.

Conditions

  • Advanced Colorectal Carcinoma
  • Advanced Digestive System Carcinoma
  • Advanced Gastric Carcinoma
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Metastatic Colorectal Carcinoma
  • Metastatic Digestive System Carcinoma
  • Metastatic Gastric Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8

Interventions

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Diagnostic Imaging

Undergo imaging

DRUG

Elimusertib

Given PO

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Liza C Villaruz · University of Pittsburgh Cancer Institute LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2024-03-29
Completion
2025-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535401 on ClinicalTrials.gov