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Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors

NCT04616534 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-05-22

No results posted yet for this study

Summary

This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.

Conditions

  • Advanced Fallopian Tube Carcinoma
  • Advanced Malignant Solid Neoplasm
  • Advanced Ovarian Carcinoma
  • Advanced Pancreatic Adenocarcinoma
  • Advanced Primary Peritoneal Carcinoma
  • Fallopian Tube High Grade Serous Adenocarcinoma
  • Metastatic Pancreatic Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Fallopian Tube Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage III Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Unresectable Pancreatic Adenocarcinoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy (dose expansion cohort only)

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Diagnostic Imaging Testing

Undergo medical imaging scans

DRUG

Elimusertib

Given PO

DRUG

Gemcitabine

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James M Cleary · Dana-Farber - Harvard Cancer Center 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
2021-06-01
Primary Completion
2025-04-01
Completion
2026-05-20
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 NCT04616534 on ClinicalTrials.gov