Study on Zoldonrasib with Chemotherapy vs. Placebo with Chemotherapy for First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Cancer

Sponsor: Revolution Medicines, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07621718

This clinical trial is testing a new drug, Zoldonrasib, combined with chemotherapy to see if it works better than a placebo with chemotherapy for treating pancreatic cancer with a specific KRAS mutation.

Patient Parameters

Parameter	Options

Program Overview

The aim of this study is to find out if a new drug called Zoldonrasib, when used with chemotherapy, can help patients with metastatic pancreatic cancer that has a specific KRAS G12D mutation live longer or have more time without the cancer getting worse, compared to a placebo with chemotherapy.

Description

This is a Phase 3 study, meaning it is in the later stages of testing. It is being conducted worldwide and involves randomly assigning patients to one of two groups. One group will receive Zoldonrasib along with a chemotherapy regimen chosen by their doctor, while the other group will receive a placebo with the same chemotherapy options. The chemotherapy options include mFFX or GnP, and the choice will be made by the patient's doctor. The study is double-blind, so neither the patients nor the doctors will know who is receiving the actual drug or the placebo. The main goal is to see if Zoldonrasib can help patients live longer or delay the progression of their cancer compared to the placebo.

Eligibility Criteria

Inclusion Criteria

Must be at least 18 years old and agree to participate.
Have a good overall health status, able to carry out normal activities or light work.
Have a confirmed diagnosis of pancreatic cancer.
The cancer must have spread to other parts of the body within the last 6 weeks.
Have a specific KRAS G12D mutation in the cancer.
Have at least one tumor that can be measured by scans.
Have good organ function, including bone marrow, liver, and kidneys.
Must be able to swallow pills.

Exclusion Criteria

Have received any cancer treatment for advanced or metastatic cancer before.
Have had any treatment targeting RAS mutations before joining the study.
Have other genetic mutations that can be treated with approved drugs.
Have untreated cancer that has spread to the brain or spinal cord.
Have any conditions that affect the ability to take or absorb the study drug.
Have had major surgery within the last 28 days.
Are unable or unwilling to attend study visits or follow study procedures.

Locations

FACILITY	ZIP	CITY	STATE
Piedmont Healthcare	30318	Atlanta	Georgia

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