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

第1相 実施中（募集終了） NCT04616534

概要

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.

Number of Patients on Treatment With Related Adverse Events

Adverse events were recorded between the first patient treated (June 2021) and 30 days out from the last patient ending treatment (October 2024) (3 years and 4 months). Adverse events were collected for a median of 88.5 days, ranging 58 - 315 days. · Participants

Maximum Tolerated Dose (MTD)

The MTD was evaluated during the dose-escalation phase, occurring from the first patient on treatment (Jun '21) through the last patient's last dose (Sep '24) (3 years and 3 months). MTD was evaluated for a median of 58.5 days, ranging 28 - 285 days. · mg

Overall Response Rate (ORR)

ORR was assessed from the time of the first patient on study (June 2021) through the last patient off study (October 2024). ORR was calculated for a median of 103 days, ranging from 30 - 312 days. · percent of participants

BENITIONS で見る ClinicalTrials.gov の原文を見る

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